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CIRB Approved Studies

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Study # Study Title CIRB Initial Review Date Group Activation Date Expiration Date

ACOSOG
ACOSOG-Z1031 
Lead Group:
ACOSOG

A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women with Clinical Stage II and III Estrogen Receptor Positive Breast Cancer
**Temporarily Closed to Accrual – Effective August 15, 2009**
**Cohort A Permanently Closed to Accrual – Effective August 15, 2009**
**Re-Open to Accrual – Effective October 1, 2009**
**Cohort B Temporarily Closed to Accrual Effective – Effective July 29, 2011**
**Cohort B reopened at Select Institutions – effective August 30, 2011**
**Cohort B Permanently Closed to Accrual – Effective December 20, 2011** 

07/19/2004   01/09/2006  04/04/2013 
ACOSOG-Z1041 
Lead Group:
ACOSOG

A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed By Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients with HER-2 positive operable breast cancer
**Closure to Accrual – Effective December 15, 2011** 

12/01/2006   07/02/2007  11/02/2012 
ACOSOG-Z4032 
Lead Group:
ACOSOG

A Randomized Phase III Study of Sublobar Resection Versus Sublobar Resection Plus Brachytherapy in High Risk Patients with Non-Small Cell Lung Cancer (NSCLC), 3cm or Smaller
**Closed to Accrual - effective January 22, 2010** 

09/14/2004   07/15/2005  02/28/2013 
ACOSOG-Z4099 
Lead Group:
ACOSOG

A Randomized Phase III Study of Sublobar Resection (+/- Brachytherapy) versus Stereotactic Body Radiation Therapy in High Risk Patients with Stage I Non-Small Cell Lung Cancer (NSCLC) 

11/18/2010   05/02/2011  08/31/2012 
ACOSOG-Z6051 
Lead Group:
ACOSOG

A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer 

11/19/2007   08/15/2008  04/04/2013 
ACOSOG-Z9031 
Lead Group:
ACOSOG
Participating Groups:
CTSU
RTOG

A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for Patients with Retroperitoneal Sarcomas (RPS)
**COMPLETED (No Further Activity is being Conducted), as of February 27, 2006** 

04/19/2004   08/23/2004   

CALGB
C80405 
Lead Group:
CALGB

A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum

**Notice of Suspension of CALGB-SWOG C80405 as of June 6, 2008-Only patients who have been consented to this study on or before, FRIDAY, JUNE 6, 2008, will be allowed to enroll on CALGB/SWOG C80405.**

**Effective November 7, 2008, CALGB/SWOG 80405, has been reactivated and is open to patient accrual.**

**Effective November 17, 2008, CALGB/SWOG 80405, has been temporarily closed to patient accrual.**

**Effective December 12, 2008, CALGB/SWOG 80405, has been Reactivated.**


**Closed to Pre-Registration of New Patients – Effective February 15, 2012**

**Closed to Registration and Randomization of New Patients – Effective March 1, 2012** 

06/20/2005   09/15/2005  10/19/2012 
CALGB-100104 
Lead Group:
CALGB

A Phase III Randomized, Double-Blind Study of Maintenance Therapy with CC-5013 (NSC #703813, IND#70116) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma
**Closed to Accrual – Effective July 3, 2009** 

06/21/2004   12/15/2004  04/18/2013 
CALGB-10201 
Lead Group:
CALGB

A Phase III Study of Daunorubicin and Cytarabine +\- G3139 (GenasenseTM, Oblimersen Sodium, NSC #683428, IND #58842), A BCL2 Antisense Oligodeoxynucleotide, in Previously Untreated Patients with Acute Myeloid Leukemia (AML) > 60 Years
**Closed to Accrual – Effective October 20, 2006** 

09/15/2003   12/15/2003  12/26/2012 
CALGB-10501 
Lead Group:
CALGB

A Phase III Intergroup CLL Study of Asymptomatic Patients with Untreated Chronic Lymphocytic Leukemia Randomized to Early Intervention Versus Observation with Later Treatment in the High Risk Genetic Subset with IgVh Unmutated Disease
**Closed to Accrual - effective January 5, 2010** 

03/19/2007   01/15/2008  02/15/2013 
CALGB-10603 
Lead Group:
CALGB

A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND #101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age with FLT3 Mutated Acute Myeloid Leukemia (AML)
** Closed to Accrual Effective – October 15, 2011** 

01/04/2008   04/01/2008  02/28/2013 
CALGB-10701 
Lead Group:
CALGB

A Phase II Study Of Dasatinib (Sprycel®) (IND #73969, NSC #732517) as Primary Therapy Followed by Transplantation for Adults >/= 50 Years with Newly Diagnosed PH+ Acute Lymphoblastic Leukemia By CALGB, ECOG and SWOG 

10/21/2010   12/15/2010  08/03/2012 
CALGB-140503 
Lead Group:
CALGB

A Phase III Randomized Trial of Lobectomy versus Sublobar Resection for Small (< 2 Cm) Peripheral Non-Small Cell Lung Cancer 

02/12/2007   06/15/2007  11/30/2012 
CALGB-30102 
Lead Group:
CALGB

Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)
**Closed to Accrual – Effective December 28, 2004**
**COMPLETED (No Further Activity is being Conducted), as of June 2, 2010** 

01/22/2002   05/15/2002   
CALGB-30506 
Lead Group:
CALGB

A Randomized Phase III Trial of Adjuvant Chemotherapy in Patients with Early Stage Non-Small Cell Lung Cancer Associated with Banking of Frozen Tumor Specimens and Collection of Gene Expression Profile Data
**Temporary Suspension to Accrual - Effective July 22, 2010**

**Reactivation: Open to Accrual– Effective October 5, 2010**

**Closure to Accrual – Effective November 30, 2011** 

01/09/2009   03/15/2009  04/18/2013 
CALGB-30607 
Lead Group:
CALGB

Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511, IND #74019) as Maintenance Therapy in Non-Progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB/IV Non-Small Cell Lung Cancer 

12/07/2007   06/15/2008  10/19/2012 
CALGB-30610 
Lead Group:
CALGB

Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide 

11/11/2007   03/15/2008  02/15/2013 
CALGB-30801 
Lead Group:
CALGB

A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer 

10/15/2009   02/15/2010  02/28/2013 
CALGB-40101 
Lead Group:
CALGB

Cyclophosphamide and Doxorubicin (CA X 4 Cycles) Versus Paclitaxel (4 Cycles) As Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes: A Phase III Randomized Study
**Closed to Accrual - Effective July 30, 2010** 

04/15/2002   05/15/2002  03/11/2013 
CALGB-40302 
Lead Group:
CALGB

Endocrine Therapy With Or Without Inhibition Of EGF And HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial Of Fulvestrant With Or Without Lapatinib (GW572016) For Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
**Closed to Accrual - Effective July 14, 2010** 

07/18/2005   09/15/2006  09/14/2012 
CALGB-40502 
Lead Group:
CALGB

A Randomized Phase III Trial Of Weekly Paclitaxel Compared To Weekly Nanoparticle Albumin Bound Nab-Paclitaxel Or Ixabepilone With Or Without Bevacizumab As First-Line Therapy For Locally Recurrent Or Metastatic Breast Cancer
**Notice of Suspension of Accrual for Arm C – Effective July 8, 2011**

**Permanently Closed to Accrual—Effective November 30, 2011** 

05/19/2008   10/13/2008  04/18/2013 
CALGB-40503 
Lead Group:
CALGB

Endocrine Therapy with or without ANTI-VEGF Therapy: A Randomized, Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865; IND 7921) for Women with Hormone Receptor-Positive Advanced Breast Cancer
**Closure to Accrual – Effective November 30, 2011** 

09/17/2007   05/15/2008  09/14/2012 
CALGB-40601 
Lead Group:
CALGB

Randomized Phase III Trial of Paclitaxel combined with Trastuzumab, Lapatinib, or Both as Neoadjuvant Treatment of HER2-Positive Primary Breast Cancer
**Closed to Accrual – Effective February 29, 2012** 

12/07/2007   12/01/2008  11/02/2012 
CALGB-49808 
Lead Group:
CALGB

A 2 X 2 X 2 Factorial Randomized Phase III Trial of Multimodality Therapy Comparing 4 Cycles of Doxorubicin and Cyclophosphamide with or without Dexrazoxane (AC +/- Z) Followed by 12 Weeks of Weekly Paclitaxel with or without Trastuzumab (T H) Followed by Local Therapy Followed by 40 Weeks of Weekly Trastuzumab or none in Women with HER-2+ STAGE IIIA, IIIB or Regional Stage IV Breast Cancer
**ADMINISTRATIVELY COMPLETED as of December 15, 2002** 

03/19/2001   05/01/2001   
CALGB-49907 
Lead Group:
CALGB

A Randomized Trial of Adjuvant Chemotherapy with Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil – (CMF) or Doxorubicin and Cyclophosphamide – (AC), Versus Capecitabine in Women 65 Years and Older with Node Positive or High-Risk Node Negative Breast Cancer
**Closed to Accrual – Effective December 29, 2006** 

08/20/2001   09/15/2001  08/28/2012 
CALGB-50303 
Lead Group:
CALGB

Phase III Randomized Study of R-CHOP v. Dose-Adjusted EPOCH-R with Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas 

10/18/2004   05/02/2005  08/31/2012 
CALGB-70301 
Lead Group:
CALGB

Quality of Life, Employment, and Informal Care Cost Analysis in Women Receiving Adjuvant Chemotherapy for Breast Cancer with 0-3 Positive Axillary Lymph Nodes: Companion to CALGB 40101
**Closed to Accrual – Effective July 30, 2010** 

06/20/2005   10/15/2005  08/18/2012 
CALGB-80101 
Lead Group:
CALGB

Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma
**Closed to Accrual – Effective May 29, 2009** 

08/19/2002   12/15/2002  03/21/2013 
CALGB-80203 
Lead Group:
CALGB

A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with and without Cetuximab (C225) for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum
**Permanently Closed to new patient accrual - Effective January 15, 2005** 

08/18/2003   12/15/2003  03/20/2013 
CALGB-80303 
Lead Group:
CALGB

A Randomized Phase III Trial of Gemcitabine Plus Bevacizumab (NSC #704865 IND# 7921) Versus Gemcitabine Plus Placebo in Patients with Advanced Pancreatic Cancer
**Closed to Accrual – Effective April 14, 2006**
**COMPLETED (No Further Activity is being Conducted), as of October 22, 2010** 

04/19/2004   06/15/2004   
CALGB-80702 
Lead Group:
CALGB

A Phase III Trial Of 6 Versus 12 Treatments Of Adjuvant Folfox Plus Celecoxib Or Placebo For Patients With Resected Stage III Colon Cancer 

03/04/2010   06/15/2010  08/31/2012 
CALGB-80802 
Lead Group:
CALGB

Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib In Patients with Advanced Hepatocellular Carcinoma (HCC) 

10/01/2009   02/15/2010  02/15/2013 
CALGB-90104 
Lead Group:
CALGB

A Randomized Phase III Study Comparing Sequential Chemotherapy (AG-TP) to Cisplatin and Gemcitabine as Adjuvant Treatment After Cystectomy for Transitional Cell Carcinoma of the Bladder
**Closed to Accrual – Effective July 15, 2005**
**COMPLETED (No Further Activity is being Conducted), as of October 6, 2010** 

06/16/2003   03/15/2004   
CALGB-90106 
Lead Group:
CALGB
Participating Groups:
CTSU

A Randomized Phase III Study of Paclitaxel, Ifosfamide and Cisplatin Versus Vinblastine, Ifosfamide and Cisplatin as Second-Line Therapy for Patients With Relapsed/Resistant Germ Cell Tumors
**ADMINISTATIVELY COMPLETED as of April 1, 2005** 

05/19/2003   04/15/2004   
CALGB-90202 
Lead Group:
CALGB

A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone
**Closed to Accrual – Effective April 4, 2012** 

04/14/2003   01/15/2004  08/31/2012 
CALGB-90203 
Lead Group:
CALGB

A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer 

10/06/2006   12/15/2006  04/18/2013 
CALGB-90206 
Lead Group:
CALGB

A Randomized Phase III Trial of Interferon Alfa-2B or Interferon Alfa-2B Plus Bevacizumab in Patients with Advanced Renal Carcinoma
**Closed to Accrual – Effective July 1, 2005** 

06/16/2003   10/01/2003  08/31/2012 
CALGB-90401 
Lead Group:
CALGB

A Randomized Double-Blinded Placebo Controlled Phase III Trial Comparing Docetaxel and Prednisone with and without Bevacizumab (IND #7921, NSC #704865) in Men with Hormone Refractory Prostate Cancer
**Closed to Accrual – Effective December 21, 2007** 

02/04/2005   04/15/2005  04/22/2013 
CALGB-90601 
Lead Group:
CALGB

A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, And Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma 

04/20/2009   07/17/2009  08/31/2012 
CALGB-90802 
Lead Group:
CALGB

Randomized Phase III Trial Comparing Everolimus Versus Everolimus Plus Bevacizumab for Advanced Renal Cell Carcinoma Progressing After Treatment with Tyrosine Kinase Inhibitors 

08/19/2010   09/15/2010  03/14/2013 

COG
AALL0331 
Lead Group:
COG


"Standard Risk B-precursor Acute Lymphoblastic Leukemia: A Phase III Group-Wide Study"
**Temporarily Closed to Accrual by COG - Effective May 2, 2008**

** Study Reactivation by COG - Effective September 29, 2008**

**Closure of HRQOL Ancillary Study by COG - Effective March 20, 2009**

**Closed to Accrual by COG - Effective May 28, 2010**
 
01/13/2005   04/11/2005  02/08/2013 
AALL03B1 
Lead Group:
COG

"Classification of Acute Lymphoblastic Leukemia"

** Temporary Suspension of Enrollment of High-Risk B-precursor Patients by COG - Effective April 25, 2008**

**Temporary Partial Closure to Accrual for Non-Infant B-precursor ALL Patients and T-cell Patients by COG - Effective May 5, 2008**

**Partial Re-activation of Accrual High-Risk B-precursor Patients by COG - Effective July 3, 2008**

**Study Reactivation by COG - Effective October 17, 2008**

**Partial Closure of Standard Risk (SR) ALL Arm to Accrual by COG of AALL03B1 - Effective May 28, 2010**

**Closed to Accrual by COG - Effective September 6, 2011**

 
01/13/2005   12/29/2003  12/08/2012 
AALL03N1 
Lead Group:
COG

"Understanding the Ethnic and Racial Differences in Survival in Children with Acute Lymphoblastic Leukemia"

**Closure of Enrollment to Caucasian Patients by COG - Effective September 11, 2006**

**Closure of Enrollment to Hispanic Patients by COG - Effective April 24, 2009**

**Closed to Accrual by COG - Effective September 9, 2011**

 
11/22/2004   05/30/2005  12/08/2012 
AALL0433 
Lead Group:
COG

"Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies. A Groupwide Phase III Study

**Temporarily Closed to Accrual by COG - Effective June 17, 2008**

**Study Reactivation by COG - Effective Monday, January 12, 2009**

**Temporarily Suspension to Accrual by COG for Patients 13 Years of Age and Older - Effective June 25, 2010**

**Temporarily Closed to Accrual by COG - Effective September 7, 2010**

**Study Reactivation by COG - Effective Monday, November 29, 2010**

 
01/26/2006   03/26/2007  04/24/2013 
AALL0434 
Lead Group:
COG

"Intensified Methotrexate, Nelarabine (Compound 506U78; IND # 52611) and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL): A Groupwide Phase III Study"

**Closure of PK Portion of AALL0434 Study - Effective August 21, 2009**
 
02/23/2006   01/22/2007  04/11/2013 
AALL05B1 
Lead Group:
COG

"A Children’s Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens"
 
12/08/2005   09/25/2006  11/17/2012 
AALL0622 
Lead Group:
COG

"Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib: IND# 73969, NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL): A Groupwide Phase II/III Study"

**Temporarily Closed to Accrual by COG - Effective October 2, 2009**

**Study Re-Activation by COG - Effective November 23, 2009**

**Temporarily Closed to Accrual by COG - Effective June 21, 2010**

**Study Re-Activation by COG - Effective September 13, 2010**

**Closed to Accrual by COG – Effective February 3, 2012**

 
01/10/2008   07/14/2008  10/12/2012 
AALL0631 
Lead Group:
COG

"A Phase III Study of Risk Directed Therapy for Infants with Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND#76431; NSC#617807)" A Groupwide Phase III Study

**Temporarily Closed to Accrual by COG - Effective November 14, 2008**

**Study Re-Activation by COG - Effective August 24, 2009**

 
07/12/2007   01/14/2008  12/07/2012 
AALL06N1 
Lead Group:
COG

"A Study of Neurocognitive Function in Children Treated for ALL: A Group-wide, Non-Therapeutic Companion Study to AALL0232"

**Temporarily Closed to Accrual - Effective April 3, 2008 **

**Study Reactivation by COG - Effective November 24, 2008**

 
10/26/2006   01/29/2007  03/07/2013 
AALL07P1 
Lead Group:
COG

"A Phase II Pilot Trial of Bortezomib (PS-341, Velcade®, IND# 58,443) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)"

 
12/11/2008   03/23/2009  12/07/2012 
AALL07P4 
Lead Group:
COG

"A Pilot Study of Intravenous EZN-2285 (SC-PEG E. coli L-asparaginase, IND# 100594) or Intravenous Oncaspar® in the Treatment of Patients with High-Risk Acute Lymphoblastic Leukemia: A Limited Institution Pilot Study"

**Temporary Suspension of Accrual - Effective July 28, 2009**

** Study Reactivation by COG - Effective September 21, 2009**

**Temporarily Closed to Accrual by COG - Effective December 22, 2010**

 
01/10/2008   07/21/2008  05/09/2013 
AALL08B1 
Lead Group:
COG

"Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)"
 
03/11/2010   08/09/2010  10/12/2012 
AALL08P1 
Lead Group:
COG

"Intensified PEG-Asparaginase in High Risk Acute Lymphoblastic Leukemia (ALL): A Pilot Study"

**Temporarily Closed to Accrual by COG - Effective April 1, 2010**

**Study Re-Activation by COG - Effective September 13, 2010**

**Temporarily Closed to Accrual by COG - Effective January 24, 2011**

**Closed to Accrual by COG - Effective March 21, 2011**

 
10/16/2008   02/23/2009  10/12/2012 
AALL0932 
Lead Group:
COG

"Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL): A Groupwide Phase III Study"
 
05/25/2010   08/09/2010  01/11/2013 
AALL1131 
Lead Group:
COG

"A Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum: A Groupwide Phase III Study"


**The Study Is Approved But Is Not Yet Open For Patient Accrual by COG - Dated September 26, 2011**

**Study Activated by COG - Effective February 27, 2012**

 
06/09/2011   02/27/2012  01/23/2013 
AAML0121 
Lead Group:
COG

"A Phase II Study of Amifostine In Children with Myelodysplastic Syndrome: A Group-wide Study" **Study Temporarily Closed to Accrual by COG as of March 17, 2006**

**Study Reactivated to Accrual by COG as of March 31, 2006**

**Study Closed to Accrual by COG as of October 23, 2006 and completed as of October 1, 2007**

 
01/14/2005   01/31/2005   
AAML0431 
Lead Group:
COG

"The Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Under the Age of 4 Years: A Groupwide Phase III Study"

**Closed to Accrual by COG – Effective December 13, 2011**

 
01/26/2006   03/26/2007  11/09/2012 
AAML0523 
Lead Group:
COG

"A Phase I/II Study of CLOLAR® (Clofarabine, IND# 73,789) in Combination with Cytarabine in Pediatric Patients with Refractory/Relapsed Leukemia"
**Temporarily Closed to Accrual by COG - Effective March 28, 2008**

**Study Reactivation by COG - Effective July 7, 2008**

**Temporarily Closed to Accrual by COG - Effective April 3, 2009**

**Study Reactivation by COG - Effective October 5, 2009**

**Temporarily Closed to Accrual by COG - Effective October 23, 2009**

**Study Reactivation by COG - Effective Monday, January 4, 2010**

**Temporarily Closed to Accrual of the AML and ALL Strata by COG - Effective August 27, 2010**

**AML stratum reopened for second-stage accrual by COG - Effective October 1, 2010**

**Permanent Closure to Accrual for ALL Stratum by COG - Effective October 22, 2010**

**Temporarily Closed to Accrual by COG - Effective October 10, 2011**

**Closed to Accrual by COG – Effective January 5, 2012**

 
04/13/2006   03/12/2007  05/01/2013 
AAML0531 
Lead Group:
COG

"A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg®) Combined with Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults"

**Closed to Accrual by COG - Effective June 15, 2010**
 
02/23/2006   08/14/2006  01/23/2013 
AAML05P1 
Lead Group:
COG

"Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Stem Cell Transplantation (SCT) for AML with Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory and Relapsed Acute Myelogenous Leukemia (AML) in Children: A Children’s Oncology Group (COG) Study (A Groupwide Pilot Study)"

 
03/08/2007   01/21/2008  10/12/2012 
AAML0631 
Lead Group:
COG

"Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® IND# 103, 331) during Consolidation: A Phase III Study Limited to COG institutions in the United States & Canada"

 
11/13/2008   03/09/2009  12/07/2012 
AAML06P1 
Lead Group:
COG

"A Pilot Study of Lestaurtinib (CEP-701) in Combination with Chemotherapy in Young Patients with Relapsed or Refractory FLT3-mutant Acute Myeloid Leukemia"

**Temporarily Closed to Accrual by COG - Effective September 26, 2008**br>
**Study Reactivation by COG - Effective October 10, 2008**

**Temporarily Closed to Accrual by COG - Effective April 10, 2009**

**Closed to Accrual by COG - Effective March 19, 2010**
 
12/14/2006   06/11/2007  04/19/2013 
AAML07P1 
Lead Group:
COG

"A Phase II Pilot Study of Bortezomib (PS-341, Velcade, IND# 58,443) Combined with Reinduction Chemotherapy in Children and Young Adults with Recurrent, Refractory or Secondary Acute Myeloid Leukemia"

**Closed to Accrual of Arm A by COG - Effective August 27, 2010 **

**Temporarily Closed to Accrual by COG - Effective November 2, 2010**

**Reactivation of Arm B by COG - Effective January 3, 2011**

**Temporarily Closed to Accrual by COG - Effective December 1, 2011**

**Closed to Accrual by COG – Effective January 11, 2012**

 
11/08/2007   04/21/2008  05/01/2013 
AAML08B1 
Lead Group:
COG

"Biology Study of Transient Myeloproliferative Disorder (TMD) in Children with Down Syndrome (DS)"
 
12/11/2008   02/23/2009  10/27/2012 
AAML1031 
Lead Group:
COG

"A Phase III Randomized Trial for Patients with de novo AML using Bortezomib (IND# 58443, NSC# 681239) and Sorafenib (BAY 43-9006, IND#69896, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD: A Groupwide Phase II/III Study"

**Partial Closure to Accrual for Arm C - Cohort 1 by COG - Effective April 9, 2012**

 
02/10/2011   06/20/2011  11/09/2012 
ABTR04B1 
Lead Group:
COG

"Establishing Continuous Cell Lines and Xenografts from Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies"
 
01/26/2006   03/05/2007  03/29/2013 
ACCL0431 
Lead Group:
COG

“A Randomized Phase III Study of Sodium Thiosulfate (IND#72877, NSC#45624) for the Prevention of Cisplatin-Induced Ototoxicity in Children: A Groupwide Phase III Study”

**Temporarily Closed to Accrual by COG – Effective January 22, 2010**

**Reactivation to Accrual by COG – Effective March 1, 2010**

**Temporarily Closed to Accrual by COG – Effective August 24, 2011**

**Study Reactivation by COG - Effective October 10, 2011**

**Temporarily Closed to Accrual by COG - Effective February 28, 2012**

 
08/23/2007   06/23/2008  09/07/2012 
ACCL04C2 
Lead Group:
COG

"Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Solid Tumors (02-AT-0172)"
**Closed to Accrual by COG - Effective January 16, 2009**
 
11/22/2004   12/12/2005   
ACCL05C1 
Lead Group:
COG

"A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy"

**Temporarily Closed to Accrual, Effective November 7, 2008**

**Study Reactivation by COG - Effective February 2, 2009**

**Temporarily Closed to Accrual by COG – Effective August 24, 2011**

**Study Reactivation by COG - Effective October 10, 2011**

**Temporarily Closed to Accrual by COG - Effective February 28, 2012**

 
06/22/2006   05/07/2007  05/01/2013 
ACCL0631 
Lead Group:
COG

"Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children with High Risk Acute Lymphoblastic Leukemia (ALL): A Group-wide Non-Therapeutic Study"

**Closed to Accrual and Administratively Completed by COG - Effective August 17, 2009**
 
05/10/2007   03/24/2008   
ACCL0922 
Lead Group:
COG

"A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor"

 
07/14/2011   07/14/2011  04/11/2013 
ACCL0933 
Lead Group:
COG

"A Randomized Open-Label Trial of Caspofungin versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML): A Groupwide Phase III Study"

 
12/09/2010   04/04/2011  05/09/2013 
ACCL0934 
Lead Group:
COG

"A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT): A Groupwide Phase III Study"

 
04/14/2011   06/20/2011  01/11/2013 
ACCL0935 
Lead Group:
COG

Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk

**Closed to Accrual by COG - Effective April 20, 2012**

 
09/08/2011   06/01/2010  09/07/2012 
ACCL1031 
Lead Group:
COG

"A Randomized Double Blinded Trial of Topical Caphosol to Prevent Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation: Phase III Study" 
12/09/2010   03/14/2011  09/07/2012 
ACCL1032 
Lead Group:
COG

"A Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Cisplatin: A Groupwide Phase III Study"

**Closed to Accrual by COG - Effective May 18, 2012**

 
03/10/2011   05/09/2011  12/07/2012 
ACCL1033 
Lead Group:
COG

"A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL: A Group-wide Non-Therapeutic Study"

 
11/10/2011   02/21/2012  11/09/2012 
ACCRN07 
Lead Group:
COG

"Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)"
 
03/08/2007   12/24/2007  02/20/2013 
ACNS0221 
Lead Group:
COG

"A Phase II Study of Conformal Radiotherapy In Patients with Low-Grade Gliomas"

**Permanent Closed to Accrual by COG - Effective December 10, 2010**

 
03/10/2005   11/28/2005  04/03/2013 
ACNS0222 
Lead Group:
COG

"A Phase II Study of Motexafin-Gadolinium (NSC 695238, IND #55583) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood: A Groupwide Phase II Study"

**Closed to Accrual - Effective November 14, 2008 at 5:00 pm**

 
04/24/2006   06/04/2007  03/18/2013 
ACNS0224 
Lead Group:
COG

"A Phase I/II Study of Topotecan with G-CSF and Radiation Therapy in Children with Malignant Intrinsic Pontine Brainstem Gliomas of Childhood."
**Closed to Accrual by COG - Effective December 21, 2007 and was completed as of February 4, 2008** 
02/24/2005   10/10/2005   
ACNS0232 
Lead Group:
COG

"Radiotherapy Alone vs. Chemotherapy Followed by Response-based Radiotherapy for Newly Diagnosed Primary CNS Germinoma: A Phase III Group-Wide Study"

**Closed to Accrual by COG - Effective May 18, 2009**
 
09/08/2005   01/29/2007  11/17/2012 
ACNS0332 
Lead Group:
COG

"Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients: A Groupwide Phase III Study"

 
04/24/2006   03/26/2007  05/09/2013 
ACNS0333 
Lead Group:
COG

"Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System with Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation: A Phase III Group-Wide Study"

**Temporary Suspension of Accrual by COG – Effective December 4, 2009**

**Study Re-Activation by COG - Effective December 27, 2010**

 
10/26/2006   12/08/2008  02/08/2013 
ACNS0334 
Lead Group:
COG

"A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs. the Same Therapy Without Methotrexate"

**Temporarily Closed to Accrual by COG - Effective April 15, 2010**

**Study Re-Activation by COG - Effective December 20, 2010**

 
10/06/2005   09/01/2005  04/11/2013 
ACNS0423 
Lead Group:
COG

"A Phase II Study of Concurrent Radiation and Temozolomide Followed by Temozolomide and Lomustine (CCNU) in the Treatment of Children with High Grade Glioma: An Intergroup Study for Participation by COG and the Dutch Childhood Oncology Group - SKION (Stichting Kinderoncologie Nederland)


**Closed to Accrual by COG - Effective October 26, 2007**

 
01/13/2005   03/21/2005  11/30/2012 
ACNS0621 
Lead Group:
COG

"Cilengitide (EMD 121974) (IND# 59073) in Recurrent or Progressive and Refractory Childhood High-Grade Glioma: A Groupwide Phase II Study"

**Temporarily Closed to Accrual by COG - Effective April 3, 2009**

** Study Reactivation by COG - Effective November 16, 2009**

**Temporarily Closed to Accrual by COG - Effective August 30, 2010**

**Permanently Closed to Accrual by COG - Effective December 31, 2010**
 
12/13/2007   06/09/2008  10/03/2012 
ACNS0821 
Lead Group:
COG

"Temozolomide with Irinotecan versus Temozolomide, Irinotecan plus Bevacizumab (NSC# 704865, BB-IND# 7921) for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, A COG Randomized Phase II Screening Trial: A Groupwide Phase II Study"

**Temporarily Closed to Accrual for Premenopausal Women by COG - Effective November 15, 2011**

**Study Reactivation by COG - Effective December 20, 2011**

 
07/08/2010   11/22/2010  01/11/2013 
ACNS0822 
Lead Group:
COG

"A Randomized Phase II/III Study of Vorinostat (IND# 71976) and Local Irradiation OR Temozolomide and Local Irradiation OR Bevacizumab (IND# 7921) and Local Irradiation Followed by Maintenance Bevacizumab and Temozolomide in Children with Newly Diagnosed High-Grade Gliomas: A Groupwide Phase II/III Study"

**Temporarily Closed to Accrual by COG - Effective March 29, 2011**

**Study Reactivation by COG - Effective August 29, 2011**

**Temporarily Closed to Accrual for Premenopausal Women by COG - Effective November 15, 2011**

**Study Reactivation by COG - Effective December 20, 2011**

 
09/08/2010   11/15/2010  01/11/2013 
ACNS0831 
Lead Group:
COG

"Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 Years: A Groupwide Phase III Study"

 
11/12/2009   03/29/2010  01/11/2013 
ACNS0927 
Lead Group:
COG

"A Phase 1/2 Study of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) and Local Irradiation, Followed By Maintenance SAHA in Children with Newly Diagnosed Diffuse Intrinsic Pontine Gliomas (DIPG)"
 
05/13/2010   08/09/2010  12/07/2012 
ACNS1021 
Lead Group:
COG

"A Phase II Study of Sunitinib (NSC# 736511, IND# 74019) in Recurrent, Refractory or Progressive High Grade Glioma and Ependymoma Tumors in Pediatric and Young Adult Patients"

 
03/10/2011   01/30/2012  12/01/2012 
ACNS1022 
Lead Group:
COG

"A Phase II Randomized Trial of Lenalidomide (NSC # 703813, IND # 70116) in Pediatric Patients with Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas: A Groupwide Phase II Study"

 
01/12/2012   03/19/2012  01/11/2013 
ADVL0221 
Lead Group:
COG

"A Phase II Study of Trabectedin (ET-743, Yondelis®) in Children with Recurrent Rhabdomyosarcoma, Ewing Sarcoma, or Nonrhabdomyosarcomatous Soft Tissue Sarcomas"

**Temporary Closure to Accrual - Effective June 13, 2008**

**Study Reactivation at Dose Level #2 - Effective September 8, 2008**

**Temporarily Closed to Accrual by COG - Effective May 13, 2009**

**Reactivation of Rhabdomyosarcoma Stratum by COG - Effective June 4, 2009**

**Temporary Closure of the Rhabdomyosarcoma Stratum by COG of ADVL0221 - Effective December 2, 2009**

**Closed to Accrual by COG - Effective April 9, 2010**

 
02/24/2005   01/28/2008  10/27/2012 
ADVL0524 
Lead Group:
COG

"Phase II Trial of Ixabepilone (BMS-247550), an Epothilone B Analog, in Children and Young Adults with Refractory Solid Tumors"


**Closed to Accrual by COG - Effective October 26, 2007**

 
11/10/2005   04/24/2006  01/29/2013 
ADVL0525 
Lead Group:
COG

"A Phase II Study of Pemetrexed in Children with Recurrent Malignancies."

**Partial Closure for Disease Strata: Osteosarcoma and Ependymoma - Effective May 22, 2009**

**Partial Closure for Medulloblastoma and Non-Brainstem High Grade Glioma Strata - Effective July 23, 2009**

**Partial Closure for Neuroblastoma Disease Strata - Effective July 30, 2009**

**Partial Closure for Ewing Sarcoma Stratum - Effective September 9, 2009**

**Closed to Accrual by COG - Effective October 26, 2009**

**COMPLETED (No Further Activity is being Conducted) as of April 4, 2012**

 
10/12/2006   09/03/2007   
ADVL06B1 
Lead Group:
COG

"A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children with Cancer"

**Stratum 5 and Stratum 7 Closed to Accrual by COG - Effective May 8, 2009**

**Stratum 3 Closed to Accrual by COG – Effective December 4, 2009**

**Reopening to Accrual of Strata 3, 5, and 7 by COG - Effective October 22, 2010**

**Reactivation of Accrual of Stratum 6 by COG - Effective February 4, 2011**

**Temporarily Closed to Accrual by COG - Effective March 16, 2011**

**Closed to Accrual by COG - Effective October 6, 2011**

 
04/12/2007   02/11/2008  10/20/2012 
ADVL0821 
Lead Group:
COG

"A Phase II Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, IND# 100947, NSC# 742460) in Children with Relapsed/Refractory Solid Tumors: A COG Groupwide Phase II Study"

**Partial Closure for Disease Strata: Osteosarcoma, Ewing Sarcoma/Peripheral PNET, and Rhabdomyosarcoma by COG of ADVL0821 – Effective May 22, 2009**
**Partial Closure of the Osteosarcoma Disease Stratum by COG of ADVL0821 - Effective June 8, 2009**
**Reactivation of Accrual for One Additional Patient for Ewing Sarcoma/Peripheral PNET Stratum - Effective July 8, 2009**
**Partial Closure for Ewing Sarcoma/Peripheral PNET Disease Stratum - Effective July 20, 2009**
**Reactivation of Accrual for Ten Additional Patients for Rhabdomyosarcoma Stratum - Effective August 19, 2009**
**Partial Closure of the Neuroblastoma (Measurable Disease) Stratum by COG of ADVL0821 -- Effective September 3, 2009**
**Partial Closure for Disease Strata: Neuroblastoma Stratum and Second-stage Accrual for the Rhabdomyosarcoma Stratum -- Effective October 9, 2009**
**Reactivation of Accrual for Ten Additional Patients for Ewing Sarcoma/Peripheral PNET Stratum – Effective October 21, 2009**

**Reactivation of Accrual for Ten Additional Patients for Neuroblastoma (MIBG+ without measurable disease) Stratum – Effective February 12, 2010**

**Partial Closure of the Wilms Stratum by COG – Effective March 2, 2010**

**Partial Closure of the Synovial Sarcoma Stratum by COG - Effective August 16, 2010**

**Partial Closure of the Hepatoblastoma Stratum by COG as of September 24, 2010**

**Partial Closure for Ewing Sarcoma/Peripheral PNET Disease Stratum by COG of COG-ADVL0821 - Effective November 12, 2010**

** Partial Closure for the Neuroblastoma (MIBG+ without Measurable Disease) Stratum by COG of COG-ADVL0821 - Effective November 30, 2010**

**Partial Closure of the Adrenocortical Carcinoma Stratum by COG of ADVL0821 - Effective 03/07/11**

**Partial Closure of the Retinoblastoma Stratum by COG of ADVL0821 - Effective March 15, 2011**

**Temporarily Closed to Accrual by COG - Effective August 15, 2011**

**Closed to Accrual by COG - Effective March 9, 2012**

 
12/11/2008   01/26/2009  12/07/2012 
ADVL0921 
Lead Group:
COG

"A Phase II Study of MLN8237 (IND# 102984), A Selective Aurora A Kinase Inhibitor in Children with Recurrent/Refractory Solid Tumors and Leukemias: A Phase II Study Limited to COG Institutions in the USA, Canada, Australia, & New Zealand"

**Partial Closure to Accrual for the MIBG+ Neuroblastoma stratum by COG - Effective May 5, 2011**

**Partial Closure to Accrual onto the AML and ALL Strata by COG - Effective May 10, 2011**

**Reactivation of ALL, AML, and MIGB+ NBL Strata by COG - Effective May 16, 2011**

** Partial Closure to Accrual: Ewing’s Sarcoma Stratum by COG - Effective June 20, 2011**

**Partial Closure to Accrual: Acute Lymphoblastic Leukemia Stratum by COG - Effective 09/19/2011**

**Partial Closure to Accrual: Osteosarcoma Stratum by COG - Effective September 27, 2011**

**Partial Closure to Accrual: Neuroblastoma (MIBG Evaluable) Stratum by COG - Effective October 3, 2011**

**Temporary Partial Closure to Accrual: Non RMS Soft Tissue Sarcoma Stratum by COG - Effective October 17, 2011**

**Partial Closure to Accrual: Neuroblastoma (Measurable) stratum - Effective 12/22/11**

 
02/22/2010   02/14/2011  05/09/2013 
ADVL1121 
Lead Group:
COG

"A Phase II Study of the Raf Kinase and Receptor Tyrosine Kinase Inhibitor Sorafenib (IND# 69896) in Children and Young Adults with Relapsed/Refractory Rhabdomyosarcoma, Wilms Tumor, Hepatocellular Carcinoma, and Papillary Thyroid Carcinoma"

 
11/10/2011   01/04/2012  11/09/2012 
AEPI05N1 
Lead Group:
COG

"Carcinogen Metabolism, DNA Repair, Parental Exposures and Retinoblastoma: A Groupwide Non-Therapeutic Study"


**Temporarily Closed to Accrual by COG - Effective December 11, 2008**

**Study Reactivation by COG - Effective March 2, 2009**
 
10/11/2007   06/02/2008  03/14/2013 
AEWS0521 
Lead Group:
COG

"A Randomized Phase II Study of Bevacizumab (NSC 704865, BB-IND# 7921) Combined with Vincristine, Topotecan and Cyclophosphamide in Patients with First Recurrent Ewing Sarcoma"

**Temporarily Closed to Accrual by COG - Effective July 1, 2008**

**Reactivation of Accrual for One Additional Stratum 1 Patient - Effective July 18, 2008**

**Temporarily Closed to Accrual by COG - Effective September 2, 2008**

**Closed to Accrual by COG - Effective August 21, 2009**

 
11/09/2006   02/25/2008  11/21/2012 
AEWS0621 
Lead Group:
COG

"Phase II Trial of Intermediate-Dose Cytarabine to Modulate EWS/FLI for Children and Young Adults with Recurrent or Refractory Ewing Sarcoma"

**Closed to Accrual by COG - Effective May 2, 2008**

**COMPLETED (No Further Activity is being Conducted) as of September 27, 2011**

 
10/12/2006   05/07/2007   
AEWS07B1 
Lead Group:
COG

"A COG Study for Collecting and Banking Ewing Sarcoma Specimens"
 
06/14/2007   02/04/2008  09/26/2012 
AEWS07P1 
Lead Group:
COG

"A Pilot Study of Chemotherapy Intensification by Adding Vincristine, Topotecan, and Cyclophosphamide to Standard Chemotherapy Agents with an Interval Compression Schedule in Newly Diagnosed Patients with Localized Ewing Sarcoma Family of Tumors"

**Temporarily Closed to Accrual by COG - Effective October 9, 2008**

**Closed to Accrual by COG - Effective January 15, 2010**

 
08/09/2007   03/03/2008  01/24/2013 
AEWS1031 
Lead Group:
COG

"A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma: A Groupwide Phase III Study"

 
08/12/2010   11/22/2010  03/07/2013 
AGCT0521 
Lead Group:
COG

"Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors with Paclitaxel, Ifosfamide and Carboplatin: A Groupwide Phase II Study"

**Temporary Closed to Accrual by COG - Effective March 7, 2011**

**Closed to Accrual by COG - Effective Jun 20, 2011**

 
11/30/2006   11/05/2007  02/14/2013 
AHEP0731 
Lead Group:
COG

"Treatment of Children with All Stages of Hepatoblastoma: A Groupwide Phase III Study"

**Temporary Closure of Stratum 4 by COG – Effective March 3, 2010**

**Reactivation of Accrual of Stratum 4 by COG – Effective August 3, 2010**

**Temporary Closure of Stratum 4 by COG - Effective Jun 6, 2011**

**Reactivation of Accrual of Stratum 4 by COG – Effective August 15, 2011**

**Temporary Closure of Stratum 4 by COG - Effective August 17, 2011**

**Reactivation of Accrual of Stratum 4 by COG – Effective January 23, 2012**

**Temporary Closure of Stratum 4 by COG - Effective February 21, 2012**

**Temporary Closure to Accrual of Stratum 3 by COG - Effective March 12, 2012**

 
05/14/2009   09/14/2009  05/09/2013 
AHOD03P1 
Lead Group:
COG

"Treatment of Children with Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD): A Groupwide Pilot Study"

**Closed to Accrual by COG - Effective November 15, 2010**

 
03/10/2005   01/02/2006  04/24/2013 
AHOD0431 
Lead Group:
COG

"A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin Disease"

**Temporary Closure to Accrual Effective December 4, 2008**

**Closed to Accrual by COG - Effective April 3, 2009**
 
04/28/2005   02/13/2006  03/29/2013 
AHOD04B1 
Lead Group:
COG

"Hodgkin Disease (HD) Banking Study"
 
06/08/2006   10/23/2006  10/03/2012 
AHOD0521 
Lead Group:
COG

"A Phase II Study of Bortezomib (Velcade, PS-341, IND #58443) in Combination with Ifosfamide/Vinorelbine in Pediatric Patients and Young Adults with Refractory/Recurrent Hodgkin Disease"

**Temporary Closure to Accrual per Protocol by COG - Effective April 28, 2008**

**Closed to Accrual by COG - Effective October 30, 2009**
 
06/22/2006   01/16/2007  10/13/2012 
AHOD0831 
Lead Group:
COG

"A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children with Newly Diagnosed High Risk Hodgkin Lymphoma: A Groupwide Phase III Study"

**Closed to Accrual by COG – Effective January 19, 2012**

 
08/13/2009   12/07/2009  12/07/2012 
ALTE05N1 
Lead Group:
COG

"Umbrella Long-Term Follow-Up Protocol"

 
12/13/2007   05/19/2008  02/21/2013 
ALTE07C1 
Lead Group:
COG

"Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children with Cancer: A Groupwide Non-Therapeutic Study"

 
05/08/2008   09/15/2008  02/14/2013 
ANBL00B1 
Lead Group:
COG

"Neuroblastoma Biology Studies"

 
01/27/2005   10/25/2005  12/01/2012 
ANBL00P3 
Lead Group:
COG

"A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients with Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated with Chemotherapy and Prednisone"

 
01/27/2005   09/21/2005  03/07/2013 
ANBL0322 
Lead Group:
COG

"A Phase II Study of hu14.18-IL2*(BB-IND-9798) In Children with Recurrent or Refractory Neuroblastoma"

**Study Temporarily Suspended by COG as of January 25, 2006**

**Closure of Stratum 2 by COG as of April 27. 2007**

**Study Closed to Accrual by COG as of September 25, 2007**

**COMPLETED (No Further Activity is being Conducted) as of May 10, 2012**

 
02/10/2005   08/15/2005   
ANBL0421 
Lead Group:
COG

"A Phase II Study of Irinotecan + Temozolomide in Children with Recurrent Neuroblastoma"

**Temporarily Closed to Accrual by COG - Effective July 18, 2008**

**Stratum 1 Closed to Enrollment by COG - Effective April 11, 2008**

**Closed to Accrual by COG - Effective December 19, 2008** 
07/14/2005   08/15/2005  11/21/2012 
ANBL0531 
Lead Group:
COG

"Response- and Biology-Based Therapy for Intermediate-risk Neuroblastoma: A Groupwide Phase III Study"


**Closed to Accrual by COG - Effective June 30, 2011**

 
11/30/2006   10/08/2007  09/07/2012 
ANBL0532 
Lead Group:
COG

"Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma"

**Temporary Suspension to Accrual by COG – Effective November 12, 2009**

**Study Re-Activation by COG - Effective April 26, 2010**

**Temporarily Closed to Accrual by COG - Effective February 23, 2012**

**Closed to Accrual by COG - Effective February 27, 2012

 
03/08/2007   11/05/2007  11/09/2012 
ANBL0931 
Lead Group:
COG

"A Comprehensive Safety Trial of Chimeric Antibody 14.18 (ch14.18) with GM-CSF, IL-2 and Isotretinoin in High-Risk Neuroblastoma Patients Following Myeloablative Therapy: A Limited Institution Study"

**Closed to Accrual by COG - Effective May 10, 2011**

 
09/10/2009   12/21/2009  12/07/2012 
ANBL09P1 
Lead Group:
COG

"A COG Pilot Study of Intensive Induction Therapy and 131I-MIBG with Myeloablative Carboplatin, Etoposide and Melphalan (CEM) for Newly Diagnosed High-Risk Neuroblastoma: A Limited Institution Pilot Study"

**Temporarily Closed to Accrual by COG - Effective October 27, 2010**

**Study Re-Activation by COG - Effective December 5, 2011**

 
05/13/2010   10/04/2010  11/09/2012 
ANBL1021 
Lead Group:
COG

"Feasibility/Phase II Study of hu14.18-IL2 immunocytokine + GM-CSF and Isotretinoin in Patients with Relapsed or Refractory Neuroblastoma: A Groupwide Phase II Study"

**Temporarily Closed to Accrual by COG - Effective November 14, 2011**

**Study Reactivation by COG - Effective February 21, 2012**

**Temporary Suspension of Accrual by COG - Effective March 20, 2012**

**Study Reactivation to Accrual by COG - Effective April 5, 2012**

 
01/13/2011   09/26/2011  09/26/2012 
ANHL04B1 
Lead Group:
COG

"Rare and Cutaneous Non-Hodgkin Lymphoma Registry"
 
01/13/2005   05/30/2005  11/21/2012 
AOST0331 
Lead Group:
COG

"A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-Operative Chemotherapy (IND# 12697): A Phase III Intergroup Study"


**Temporary Suspension to Accrual - Effective January 27, 2011**

**Study Re-Activation by COG - Effective March 14, 2011**

**Closed to Accrual by COG - Effective June 30, 2011**

 
01/27/2005   11/14/2005  03/07/2013 
AOST06B1 
Lead Group:
COG

"A Children’s Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens"

 
12/28/2006   02/04/2008  03/14/2013 
AOST06P1 
Lead Group:
COG

"Feasibility and Dose Discovery Analysis of Zoledronic Acid with Concurrent Chemotherapy in the Treatment of Newly Diagnosed Metastatic Osteosarcoma"


**Temporarily Closed to Accrual by COG - Effective March 31, 2009**

** Study Reactivation by COG - Effective May 25, 2009**

**Temporarily Closed to Accrual by COG - Effective April 7, 2010**

**Study Reactivation by COG - Effective May 21, 2010**

**Temporarily Closed to Accrual by COG - Effective August 11, 2010**

**Closed to Accrual by COG - Effective March 9, 2012**

 
10/11/2007   08/25/2008  01/11/2013 
ARAR0331 
Lead Group:
COG

"Treatment of Childhood Nasopharyngeal Carcinoma with Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study"

**Temporarily Closed to Accrual by COG - Effective January 17, 2012**

 
03/10/2005   02/20/2006  03/07/2013 
ARAR0332 
Lead Group:
COG

"Treatment of Adrenocortical Tumors with Surgery plus Lymph Node Dissection and Multiagent Chemotherapy: A Groupwide Phase III Study"
 
03/10/2005   09/18/2006  10/12/2012 
AREN0321 
Lead Group:
COG

"Treatment of High Risk Renal Tumors: A Groupwide Phase II Study"

**Enrollment Suspended for Stratum 20 by COG - Effective September 11, 2007**

**Immediate Suspension of Accrual of Patients to the Regimen UH-1 and Window Therapy Arms - Effective October 28, 2008**

**Temporary Suspension of Accrual onto the Window Therapy Arm - Effective January 20, 2010**

**Reactivation of Enrollment on COG-AREN0321 Window Therapy Arm by COG - Effective February 1, 2010**

**Temporary Suspension of Accrual onto Revised UH-1 and Window Therapy Arms by COG – Effective March 16, 2011**

 
07/28/2005   06/19/2006  02/08/2013 
AREN03B2 
Lead Group:
COG

"Renal Tumors Classification, Biology, and Banking Study"
 
07/28/2005   02/27/2006  05/01/2013 
AREN0532 
Lead Group:
COG

"Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor: A Groupwide Phase III Study"

 
04/13/2006   10/30/2006  09/07/2012 
AREN0533 
Lead Group:
COG

"Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors: A Groupwide Phase III Study"
 
04/13/2006   02/26/2007  09/07/2012 
AREN0534 
Lead Group:
COG

"Treatment for Patients with Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor: A Groupwide Phase III Study"

**Temporary Suspension of Accrual onto Revised UH-1 Arm by COG – Effective March 16, 2011**

 
06/14/2007   07/13/2009  01/11/2013 
ARET0231 
Lead Group:
COG

"A Single Arm Trial of Systemic and Subtenon Chemotherapy for Groups C and D Intraocular Retinoblastoma"

**Closed to Accrual by COG - Effective January 28, 2011**
 
10/06/2005   04/16/2007  10/27/2012 
ARET0321 
Lead Group:
COG

"A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma: A Groupwide Phase III Study"
 
01/12/2006   02/04/2008  10/12/2012 
ARET0331 
Lead Group:
COG

"Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma: A Phase III Limited Institution Study"

**Temporarily Closed to Accrual and Treatment - Effective December 19, 2008**

**Study Reactivation by COG - Effective May 4, 2009**

**Closed to Accrual by COG - Effective June 18, 2009**

 
02/10/2005   12/26/2005  01/24/2013 
ARET0332 
Lead Group:
COG

"A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy: A Groupwide Phase III Study"

**Closed to Accrual by COG - Effective May 14, 2010**

 
02/24/2005   12/12/2005  02/06/2013 
ARST0332 
Lead Group:
COG

"Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age: A Groupwide Phase III Study"

**Closed to Accrual by COG – Effective February 10, 2012**

 
12/08/2005   02/05/2007  03/07/2013 
ARST03P1 
Lead Group:
COG

"A Pilot Phase II Study for Children with Infantile Fibrosarcoma"

**Closed to Accrual - Effective January 19, 2007 at 5 PM ET**

**ADMINISTRATIVELY COMPLETED as of February 28, 2008**
 
02/24/2005   07/22/2005   
ARST0431 
Lead Group:
COG

"Intensive Multi-Agent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide (IE) and Vincristine/Doxorubicin/Cyclophosphamide (VDC) for Patients with High-Risk Rhabdomyosarcoma: A Groupwide Phase III Study"

**Closed to Accrual by COG - Effective June 13, 2008 5 p.m. EST**

 
12/08/2005   07/17/2006  01/31/2013 
ARST0531 
Lead Group:
COG

"Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS): A Groupwide Phase III Study"
 
01/12/2006   12/26/2006  02/08/2013 
ARST08P1 
Lead Group:
COG

"A Pilot Study to Evaluate Novel Agents (Temozolomide and Cixutumumab [IMC-A12, Anti-IGF-IR Monoclonal Antibody, IND #100947, NSC # 742460]) in Combination with Intensive Multi-Agent Interval Compressed Therapy for Patients with High-Risk Rhabdomyosarcoma: A Groupwide Pilot Study"

** Suspend Accrual for Cohort 1A by COG - Effective September 10, 2010**

** Open Accrual for Cohort 2 by COG - Effective September 10, 2010**

** Suspend Accrual for Cohort 2 by COG - Effective February 4, 2011**

** Open Accrual for Cohort 1B by COG - Effective February 4, 2011**

**Closure of Cohort 1B by COG - Effective July 11, 2011**

**Closure of Cohort 2 by COG - Effective November 18, 2011**

 
11/12/2009   01/19/2010  01/11/2013 
ARST0921 
Lead Group:
COG

"A Randomized Phase II Trial of Bevacizumab (IND# 7921, Avastin) and Temsirolimus (IND# 61010, Torisel) in Combination with Intravenous Vinorelbine and Cyclophosphamide in Patients with Recurrent/Refractory Rhabdomyosarcoma: A Groupwide Phase II Study"


**Temporarily Closed to Accrual by COG - Effective August 30, 2011**

**Study Reactivation by COG - Effective November 14, 2011**

 
08/12/2010   10/25/2010  02/08/2013 
ASCT0431 
Lead Group:
COG

"A Randomized Trial of Sirolimus-Based Graft versus Host Disease Prophylaxis after Hematopoietic Stem Cell Transplantation in Selected Patients with CR1 and CR2 ALL: A Groupwide Phase III Study"

**Temporarily Closed to Accrual by COG - Effective September 14, 2010**

**Study Re-Activation by COG - Effective October 29, 2010**

**Closed to Accrual by COG - Effective May 10, 2011**

 
02/23/2006   03/19/2007  10/12/2012 
ASCT0631 
Lead Group:
COG

"A Phase III Randomized Trial of G-CSF Stimulated Bone Marrow vs. Conventional Bone Marrow as a Stem Cell Source In Matched Sibling Donor Transplantation"

**Temporary Closure to Accrual by COG - Effective October 10, 2008**

**Study Reactivation by COG - Effective June 14, 2010**

**Closed to Accrual by COG - Effective November 25, 2011**

 
10/26/2006   12/31/2007  02/08/2013 
ASCT0631D 
Lead Group:
COG

"A Comparison of Acute and Long-term Toxicities in Bone Marrow Donors with and without G-CSF Treatment Prior to Harvest: A Companion Study to ASCT0631"

**Closed to Accrual by COG – Effective November 25, 2011**

**COMPLETED as of December 14, 2011**

 
02/22/2010   06/14/2010  09/07/2012 
D9902 
Lead Group:
COG

"A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol"
 
12/08/2005   02/20/2006  09/27/2012 

ECOG
E1105 
Lead Group:
ECOG

A Randomized Phase III Double-Blind Placebo-Controlled Trial of First-line Chemotherapy and Trastuzumab with or without Bevacizumab for Patients with HER-2/NEU Over-expressing Metastatic Breast Cancer
**Closed to Accrual - effective October 28, 2009** 

10/20/2006   11/09/2007  09/14/2012 
E1208 
Lead Group:
ECOG

A Phase III Randomized, Double-Blind Trial of Chemoembolization with or without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients with and without Vascular Invasion 

08/20/2009   10/28/2009  01/04/2013 
E1301 
Lead Group:
ECOG

A Phase III Randomized Study of Adjuvant Biologic Therapy in Patients With States III/IV Head and Neck Squamous Cell Carcinoma
**Closed to Accrual - Effective December 20, 2004**
**COMPLETED (No Further Activity Being Conducted) as of November 25, 2009** 

05/13/2002   02/21/2003   
E1302 
Lead Group:
ECOG

Phase III Randomized, Placebo-Controlled Trial of Docetaxel Versus Docetaxel Plus ZD1839 (Iressa, gefitnib) in Performance Status 2 or Previously Treated Patients with Recurrent or Metastatic Head and Neck Cancer
**Partial closure: Arm C (step 2) has been permanently closed as of 8/22/07**

**Closed to Accrual – Effective November 13, 2008** 

02/09/2004   08/06/2004  04/08/2013 
E1305 
Lead Group:
ECOG

A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer 

11/20/2006   08/08/2008  07/20/2012 
E1505 
Lead Group:
ECOG

A Phase III Randomized Trial of Adjuvant Chemotherapy with or without Bevacizumab for Patients with Completely Resected Stage IB (>= 4 cm) -IIIA Non-Small Cell Lung Cancer (NSCLC) 

01/23/2006   06/01/2007  09/14/2012 
E1609 
Lead Group:
ECOG

A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma 

07/01/2010   05/25/2011  01/18/2013 
E1899 
Lead Group:
ECOG

Phase III Randomized Trial for Evaluating Second Line Hormonal Therapy (Ketoconazole/Hydrocortisone) versus Docetaxel/Estramustine Combination Chemotherapy on Progression Free Survival in Asymptomatic Patients with a Rising PSA after Hormonal Therapy for Prostate Cancer
**Closed to Accrual – Effective December 28, 2004, **
**COMPLETED (No Further Activity is being Conducted), as of February 4, 2010** 

07/15/2002   10/31/2002   
E1900 
Lead Group:
ECOG

A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose- Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation
**Accrual Suspended as of Feb 16, 2008 - No new patients should be enrolled into this study** **RE-OPENED TO ACCRUAL, as of April 29, 2008** **ClOSED TO ACCRUAL, as of November 17, 2008**  

03/18/2002   12/16/2002  11/16/2012 
E1A00 
Lead Group:
ECOG

A Randomized Phase III Trial of Thalidomide (NSC #66847) Plus Dexamethasone Versus Dexamethasone in Newly Diagnosed Multiple Myeloma
**Closed to Accrual – Effective April 18, 2003**

**COMPLETED (No Further Activity Being Conducted) as of April 25, 2012** 

11/13/2001   04/17/2002   
E1A05 
Lead Group:
ECOG

Randomized Phase III Trial of Consolidation Therapy with Bortezomib (Velcade®) - Lenalidomide (Revlimid®) - Dexamethasone (VRD) versus Bortezomib (Velcade®) - Dexamethasone (VD) for Patients with Multiple Myeloma Who Have Completed a Dexamethasone Based Induction

**Closed to Accrual – Effective May 7, 2010** 

02/12/2007   09/06/2007  02/28/2013 
E1A06 
Lead Group:
ECOG

An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid TM) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy

** Closed to Accrual Effective – November 30, 2011** 

04/06/2007   02/29/2008  03/14/2013 
E1Y03 
Lead Group:
ECOG

Master Protocol for Pharmacogenetic and Genomic Studies.
**Closed to Accrual – Effective October 15, 2008* 

02/22/2005   09/15/2004  02/17/2013 
E2100 
Lead Group:
ECOG

A Randomized Phase III Trial of Paclitaxel versus Paclitaxel plus Bevacizumab (rhuMAb VEGF) as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer
**Closed to Accrual – Effective May 26, 2004** 

08/20/2001   12/21/2001  05/16/2013 
E2108 
Lead Group:
ECOG

A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer 

04/01/2010   02/08/2011  09/14/2012 
E2499 
Lead Group:
ECOG

Randomized Phase III Trial of Rituximab (NSC #687451) and Autologous Stem Cell Transplantation for B Cell Diffuse Large Cell Lymphoma
**Closed to Accrual, Effective May 2, 2006**
**COMPLETED (No Further Activity is being Conducted), as of June 2, 2010** 

09/17/2002   03/27/2003   
E2603 
Lead Group:
ECOG

A Double-blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and Sorafenib Versus Carboplatin, Paclitaxel and Placebo in Patients with Unresectable Locally Advanced or Stage IV Melanoma
**Closed to Accrual - effective April 22, 2008** 

09/13/2004   06/23/2005  02/23/2013 
E2805 
Lead Group:
ECOG

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
**Closed to Accrual – effective September 1, 2010** 

12/19/2005   04/24/2006  04/22/2013 
E2902 
Lead Group:
ECOG

A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure or Patients over Age 60 in First Remission
**CTSU Re-Activation Date: 2/7/08**
**Closed to Accrual - effective December 7, 2009** 

11/17/2003   08/18/2004  11/30/2012 
E2905 
Lead Group:
ECOG

A Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid®) Alone and in Combination with Epoetin Alfa (Procrit®) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia
**Temporary Suspension of Accrual – effective September 24, 2010**
**Re-Open to Accrual – effective February 4, 2011** 

07/21/2008   01/29/2009  09/14/2012 
E2906 
Lead Group:
ECOG

Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age >/= 60 Years) 

10/03/2008   12/28/2010  09/14/2012 
E3200 
Lead Group:
ECOG

Phase III Trial of Bevacizumab (NSC 704865), Oxaliplatin (NSC 266046), Fluorouracil and Leucovorin versus Oxaliplatin, Fluorouracil and Leucovorin versus Bevacizumab Alone in Previously Treated Patients with Advanced Colorectal Cancer
**COMPLETED (No Further Activity is being Conducted) as of April 20, 2007** 

07/16/2001   10/30/2001   
E3201 
Lead Group:
ECOG

Intergroup Randomized Phase III Study of Postoperative Irinotecan, 5-Fluorouracil and Leucovorin Vs Oxaliplatin, 5-Fluorouracil and Leucovorin Vs 5-Fluorouracil and Leucovorin For Patients with Stage II or III Rectal Cancer Receiving Either Preoperative Radiation and 5-Fluorouracil or Postoperative Radiation and 5-Fluorouracil
**Closed to Accrual – Effective November 1, 2005** 

02/17/2003   10/15/2003  12/26/2012 
E3805 
Lead Group:
ECOG

CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer 

07/18/2005   07/28/2006  05/02/2013 
E3999 
Lead Group:
ECOG

A Randomized, Placebo-controlled, Double Blind, Trial of the Administration of the MDR Modulator, Zosuquidar trihydrochloride (LY335979), During Conventional Induction and Post-Remission Therapy in Patients Greater than 60 Years of Age with Newly Diagnosed Acute Myeloid Leukemia, Refractory Anemia with Excess Blasts in Transformation or High-Risk Refractory Anemia with Excess Blasts
**Closed to Accrual – Effective September 15, 2005**

**ECOG has Discontinued Activation of any New Sites to this Study - Effective April 19, 2005**

**COMPLETED (No Further Activity Being Conducted) as of April 30, 2012** 

05/13/2002   07/17/2002   
E3A06 
Lead Group:
ECOG

Randomized Phase III Trial of Lenalidomide versus Observation Alone In Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma
**Accrual Suspended - Effective December 16, 2011** 

05/20/2010   10/05/2010  12/14/2012 
E3F05 
Lead Group:
ECOG

Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas 

06/18/2007   09/11/2009  11/30/2012 
E4201 
Lead Group:
ECOG

A Randomized Phase III Study of Gemcitabine in Combination with Radiation Therapy Versus Gemcitabine Alone in Patients with Localized, Unresectable Pancreatic Cancer
**Closed to Accrual – Effective December 15, 2005**
**COMPLETED (No Further Activity Being Conducted) as of December 28, 2010** 

11/12/2002   04/10/2003   
E4402 
Lead Group:
ECOG

Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens for Patients with Low Tumor Burden Indolent Non-Hodgkin''s Lymphoma
** Closed to Accrual - Effective September 12, 2008 ** 

07/21/2003   11/21/2003  05/16/2013 
E4599 
Lead Group:
ECOG

Randomized Phase II/III Trial of Paclitaxel plus Carboplatin With or Without Bevacizumab (NSC #704865) in Patients with Advanced Nonsquamous NSCLC
**Closed to Accrual – Effective April 7, 2004**
**COMPLETED (No Further Activity Being Conducted) as of December 8, 2010** 

08/13/2001   07/19/2001   
E4A03 
Lead Group:
ECOG

A Randomized Phase III Study of CC-5013 Plus Dexamethasone Versus CC-5013 Plus Low Dose Dexamethasone in Multiple Myeloma with Thalidomide Plus Dexamethasone Salvage Therapy for Non-Responders
**Suspended to Accrual – Effective September 14, 2005**
**Reactivated to Accrual – Effective November 23, 2005**
**Closed to Accrual - Effective June 1, 2007** 

05/17/2004   10/26/2004  09/14/2012 
E4A08 
Lead Group:
ECOG

A Randomized Phase III Trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan, and Dexamethasone (BMDex) for Untreated Patients with Systemic Light-chain (AL) Amyloidosis Ineligible for Autologous Stem-cell Transplantation 

09/17/2009   11/01/2010  02/28/2013 
E5103 
Lead Group:
ECOG

A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
**Enrollment SUSPENSION – Effective September 24, 2009**

**RE-OPEN TO ACCRUAL EFFECTIVE December 18, 2009**

**Step 1 Closure to Accrual – Effective February 28, 2011** 

08/21/2006   11/02/2007  02/15/2013 
E5202 
Lead Group:
ECOG

A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin Versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers
**Suspension of Accrual – Effective April 29, 2009**

**Re-Open to Accrual – Effective August 10, 2009**

**Suspension of Accrual – Effective October 7, 2010**

**Closure to Accrual – Effective February 11, 2011** 

09/20/2004   08/04/2005  02/01/2013 
E5204 
Lead Group:
ECOG

Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil, and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-Operative Chemoradiation
**Closed to Accrual – Effective April 29, 2009** 

12/02/2005   02/17/2006  02/28/2013 
E5508 
Lead Group:
ECOG

Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC 

11/19/2009   08/12/2010  04/04/2013 
E6201 
Lead Group:
ECOG

A Phase III, Randomized Study of Gemcitabine [fixed-dose rate infusion] and Oxaliplatin (NSC 266046) versus Gemcitabine [fixed-dose rate infusion] versus Gemcitabine [30-minute infusion] in Pancreatic Carcinoma
**COMPLETED (No Further Activity is being Conducted), as of February 4, 2008** 

10/01/2002   03/26/2003   
PACCT-1 
Lead Group:
ECOG

Program For The Assessment of Clinical Cancer Test (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial
**Closed to Accrual – Effective October 6, 2010** 

11/21/2005   04/07/2006  09/14/2012 

GOG
ANZGOG-0902-GOG-0274 
Lead Group:
GOG

A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: THE OUTBACK TRIAL (ANZGOG 0902) 

08/04/2011   07/25/2011  05/16/2013 
GOG-0198 
Lead Group:
GOG

A Randomized Study of Tamoxifen Versus Thalidomide (NSC # 66847) in Patients with Biochemical-Recurrence-Only Epithelial Ovarian Cancer, Cancer of the Fallopian Tube, and Primary Peritoneal Carcinoma after First Line Chemotherapy
**Closed to Accrual – Effective July 23, 2007**
**COMPLETED (No Further Activity Being Conducted) as of June 6, 2011** 

03/18/2002   02/03/2003   
GOG-0201 
Lead Group:
GOG

Treatment of Patients with Stage IB2 Carcinoma of the Cervix A Randomized Comparison of Radical Hysterectomy and Tailored Radiation Versus Primary Chemo Radiation
**COMPLETED (No Further Activity Being Conducted) as of April 28, 2005** 

08/19/2002   01/13/2003   
GOG-0204 
Lead Group:
GOG

A Randomized Phase III Trial of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix
**Closed to Accrual – Effective April 30, 2007**
**COMPLETED (No Further Activity Being Conducted) as of June 13, 2011** 

03/17/2003   05/27/2003   
GOG-0209 
Lead Group:
GOG

Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF Versus Carboplatin/Paclitaxel in Patients with Stage III & IV or Recurrent Endometrial Cancer
**SUSPENSION OF ENTRY TO PATIENTS WITH PRIOR EXTERNAL RADIATION THERAPY, EFFECTIVE 7/23/2007 ** **RE-ENTRY OF SUBJECTS WITH PRIOR EXTERNAL RADIATION THERAPY, EFFECTIVE 2/11/2008**
**Closed to Accrual – Effective April 20, 2009** 

03/17/2003   08/25/2003  10/19/2012 
GOG-0212 
Lead Group:
GOG

A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or CT 2103 (IND# 70177) Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancer who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy 

01/07/2005   03/21/2005  09/14/2012 
GOG-0213 
Lead Group:
GOG

A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in Combination with Bevacizumab (NSC #704865, IND #113912) followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer 

06/01/2007   12/06/2007  10/05/2012 
GOG-0218 
Lead Group:
GOG

A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC #704865, IND #113912) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Stage III or IV, Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
**Suspension of Accrual – Effective June 29, 2009**
**Closed to Accrual – Effective August 10, 2009** 

05/06/2005   09/26/2005  12/05/2012 
GOG-0219 
Lead Group:
GOG

A Phase III, Randomized Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine (#46525) and Radiation in Stage IB2, IIA, IIB, IIIB, and IVA Cervical Carcinoma Limited to the Pelvis
**Study Suspended to Patient Entry effective September 1, 2009**
**Closed to Accrual - effective September 1, 2009** 

04/18/2005   02/06/2006  08/29/2012 
GOG-0240 
Lead Group:
GOG

: A Randomized Phase III Trial of Cisplatin plus Paclitaxel with and without NCI-Supplied Bevacizumab (NSC #704865, IND #113912) Versus the Non-Platinum Doublet, Topotecan Plus Paclitaxel, with and without NCI-Supplied Bevacizumab, in Stage IVB, Recurrent or Persistent Carcinoma of the Cervix
**Closed to Accrual – Effective January 3, 2012** 

06/16/2008   04/06/2009  10/19/2012 
GOG-0241 
Lead Group:
GOG

A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865, IND #113912) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients with Mucinous Epithelial Ovarian or Fallopian Tube Cancer (MEOC) 

09/02/2010   10/12/2010  04/18/2013 
GOG-0249 
Lead Group:
GOG

A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed By Paclitaxel/Carboplatin Chemotherapy in Patients with High Risk, Early Stage Endometrial Carcinoma 

10/03/2008   03/23/2009  11/30/2012 
GOG-0250 
Lead Group:
GOG

A Randomized Phase III Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF with Bevacizumab (NSC #704865, IND #113912) Versus Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF with Placebo in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus. NCI Supplied Agent: Bevacizumab (NSC #704865, IND #113912) 

05/21/2009   11/09/2009  10/19/2012 
GOG-0252 
Lead Group:
GOG

A Phase III Clinical Trial of Bevacizumab with IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma NCI-Supplied Agent(s): Bevacizumab (NSC #704865, IND #113912))
**Closed to Accrual—Effective November 30, 2011** 

05/21/2009   07/27/2009  10/19/2012 
GOG-0258 
Lead Group:
GOG

A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma 

07/16/2009   08/12/2009  12/14/2012 
GOG-0261 
Lead Group:
GOG

A Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naïve Patients with Newly Diagnosed Stage I-IV, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus or Ovary 

08/06/2009   08/17/2009  01/04/2013 
GOG-0262 
Lead Group:
GOG

GOG-0262: A Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel In Combination With Carboplatin With Or Without Concurrent and Consolidation Bevacizumab (NSC #704865, IND #113912) in the Treatment of Primary Stage II, III OR IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer and ACRIN 6695: Perfusion CT Imaging To Evaluate Treatment Response in Patients Participating in GOG-0262
**Suspended to Patient Entry – Effective February 8, 2012**

**Re-opened patient entry - Effective April 30, 2012** 

07/01/2010   09/27/2010  02/01/2013 
GOG-0263 
Lead Group:
GOG

Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation In Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy 

04/15/2010   05/25/2010  10/19/2012 

NCCTG
N0147 
Lead Group:
NCCTG

A Randomized Phase III Trial of Oxaliplatin (OXAL) plus 5-Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer

**Suspension of Accrual – Effective Friday June 6, 2008**

**Study will Re-Open to Accrual – Effective August 18, 2008 **

**Effective October 24, 2008 at 8:00 AM CDT accrual of patients 70 years of age and older is temporarily suspended.** **

**Effective May 8, 2009, NO147 will reopen to accrual of patients 70 years of age and greater.**

**Closed to Accrual - effective November 25, 2009** 

09/15/2003   02/10/2004  03/04/2013 
N0434 (MA.27D) 
Lead Group:
NCCTG

The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27

**Closed to Accrual - Effective July 31, 2008** 

09/19/2005   12/08/2005  02/09/2013 
N0574 
Lead Group:
NCCTG

Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients with One to Three Cerebral Metastases 

05/05/2006   07/28/2006  08/03/2012 
N0577 
Lead Group:
NCCTG

Phase III Intergroup Study of Radiotherapy versusTemozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide forPatients with 1p/19q Codeleted Anaplastic Glioma
**Temporarily Closed to Accrual - Effective December 20, 2011** 

12/15/2008   09/22/2009  02/01/2013 
N0723 
Lead Group:
NCCTG

MARVEL: Marker Validation of Erlotinib in Lung Cancer - A Phase III Biomarker Validation Study of Second-line Therapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed versus Erlotinib.
**Closed to Accrual - effective November 13, 2009** 

04/21/2008   10/01/2008  04/18/2013 
N0949 
Lead Group:
NCCTG

Randomized Phase III Trial of mFOLFOX7 or XELOX Plus Bevacizumab Versus 5-Fluorouracil/Leucovorin or Capecitabine Plus Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer 

12/16/2010   01/21/2011  08/31/2012 
N1048 
Lead Group:
NCCTG

A Phase II/III trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision 

10/20/2011   01/13/2012  10/19/2012 
N107C 
Lead Group:
NCCTG

A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease 

06/02/2011   07/08/2011  03/14/2013 
NCCTG-N06C6 
Lead Group:
NCCTG

A Phase III Randomized Trial of Cryoablation vs. Radiation for the Palliation of Painful Bone Metastases
**Closed to Accrual – Effective June 19, 2009**
**COMPLETED (No Further Activity is being Conducted), as of January 29, 2010** 

06/01/2007   02/08/2008   

NCIC CTG
NCIC-BR.19 
Lead Group:
NCIC CTG

A Phase III Prospective Randomized, Double-Blind, Placebo-Controlled Trial of the Epidermal Growth Factor Receptor Antagonist, ZD1839 (IRESSA) in Completely Resected Primary Stage IB, II and IIIA Non-Small Cell Lung Cancer
**Closed to Accrual – Effective April 22, 2005, **

**Accrual on Hold Unitl Further Notice-Effective April 15, 2005**

**COMPLETED (No Further Activity Being Conducted) as of January 6, 2012** 

06/17/2002   09/20/2002   
NCIC-MA.27 
Lead Group:
NCIC CTG

A Randomized Phase III Trial of Exemestane Versus Anastrozole in PostMenopausal Women With Receptor Positive Primary Breast Cancer
**Closed to Accrual – Effective July 31, 2008**
**COMPLETED (No Further Activity Being Conducted) as of June 13, 2011** 

01/21/2003   06/30/2003   
NCIC-MA.27B 
Lead Group:
NCIC CTG

The Influence of Five Years of Adjuvant Anastrozole or Exemestane on bone Mineral Density in Postmenopausal Women with Primary Breast Cancer - A Companion Study to NCIC CTG MA.27
**Closed to Accrual – Effective May 30, 2008**
**COMPLETED (No Further Activity Being Conducted) as of July 8, 2011** 

12/19/2005   04/24/2006   
NCIC-MA.32 
Lead Group:
NCIC CTG

A Phase III Randomized Trial Of Metformin Versus Placebo On Recurrence And Survival In Early Stage Breast Cancer
**Suspension of Accrual – Effective August 31, 2010**
**Re-Activation for US Participation – Effective May 13, 2011 **
**Closure to Accrual to Quality of Life, Physical Activity, and Diet Questionnaires – Effective November 4, 2011** 

03/04/2010   07/08/2010  08/31/2012 
NCIC-PR.11 
Lead Group:
NCIC CTG

A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer (START)
**Closed to Accrual – Effective May 13, 2011 ** 

02/02/2007   06/15/2007  10/19/2012 

NSABP
NSABP-B-33 
Lead Group:
NSABP

A Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of Exemestane in Clinical Stage T1-3N0-1M0 Postmenopausal Breast Cancer Patients Completing at Least Five Years of Tamoxifen Therapy
**Closed to Accrual – Effective October 14, 2003**

**COMPLETED (No Further Activity is being Conducted), as of March 30, 2011**
 

02/20/2001   05/01/2001   
NSABP-B-34 
Lead Group:
NSABP

A Clinical Trial Comparing Adjuvant Clodronate Therapy vs. Placebo in Early-Stage Breast Cancer Patients Receiving Systemic Chemotherapy and/or Hormonal Therapy or No Therapy
**Closed to Accrual – Effective March 31, 2004 ** 

01/22/2001   12/01/2000  08/29/2012 
NSABP-B-35 
Lead Group:
NSABP

A Clinical Trial Comparing Anastrozole with Tamoxifen in Postmenopausal Patients with Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy with Radiation Therapy
**Closed to Accrual – Effective June 15, 2006** 

05/13/2002   01/06/2003  11/02/2012 
NSABP-B-36 
Lead Group:
NSABP

A Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC) in Patients with Node-Negative Breast Cancer
**Closed to Accrual – Effective July 25, 2008** 

06/16/2003   05/20/2004  08/29/2012 
NSABP-B-38 
Lead Group:
NSABP

A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens in Women with Node-Positive Breast Cancer: Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed by DD Paclitaxel (DD AC->P); DD AC Followed by DD Paclitaxel Plus Gemcitabine (DD AC->PG)
**Closed to Accrual – Effective May 3, 2007** 

05/17/2004   10/01/2004  08/29/2012 
NSABP-B-39 
Lead Group:
NSABP

A Randomized Phase III Trial of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer
** Closure of Accrual to BAHO Substudy: Quality of Life (QOL), Cosmesis, and Digital Photos Assessments– Effective May 28, 2009** 

09/20/2004   03/21/2005  02/15/2013 
NSABP-B-40 
Lead Group:
NSABP

A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel when Administered Before AC with or without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR with Each of the Regimens
**Closed to Accrual - Effective June 30, 2010** 

07/18/2005   11/20/2006  11/30/2012 
NSABP-B-42 
Lead Group:
NSABP

A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer
**Closed to Accrual - effective January 6, 2010** 

03/20/2006   08/14/2006  11/02/2012 
NSABP-B-43 
Lead Group:
NSABP

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma in Situ Resected by Lumpectomy 

05/04/2007   11/13/2008  02/28/2013 
NSABP-B-47 
Lead Group:
NSABP

A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer 

12/03/2009   01/06/2011  04/18/2013 
NSABP-B-49 
Lead Group:
NSABP

A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer 

03/01/2012   04/04/2012  02/28/2013 
NSABP-C-08 
Lead Group:
NSABP

A Phase III Clinical Trial Comparing Infusional 5-Fluorouracil (5-FU), Leucovorin, and Oxaliplatin (mFOLFOX6) Every Two Weeks with Bevacizumab to the Same Regimen without Bevacizumab for the Treatment of Patients with Resected Stages II and III Carcinoma of the Colon
**Closed to Accrual – Effective October 6, 2006** 

04/19/2004   09/15/2004  05/08/2013 
NSABP-C-09 
Lead Group:
NSABP

A Phase III Clinical Trial Comparing Oxaliplatin, Capecitabine, and Hepatic Arterial Infusion of Floxuridine to Oxaliplatin and Capecitabine in Patients with Resected or Ablated Liver Metastases from Colorectal Cancer.
**ADMINISTRATIVELY COMPLETED as of July 28, 2009** 

05/06/2005   01/05/2006   
NSABP-C-11 
Lead Group:
NSABP

A Phase III Study Evaluating the Role of Perioperative Chemotherapy in Patients with Potentially Resectable Hepatic Colorectal Metastases
**Suspension of Accrual – Effective October 8, 2010**

**Re-Activation of Accrual – Effective February 3, 2011 **

**Closed to Accrual—Effective December 16, 2011**

**COMPLETED (No Further Activity Being Conducted) as of April 9, 2012** 

12/03/2009   08/23/2010   
NSABP-NCIC-CTG-MA.32.F 
Lead Group:
NSABP

Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer 

02/03/2011   07/11/2011  11/16/2012 
NSABP-R-04 
Lead Group:
NSABP

A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion of 5-Fluorouracil with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum
**Closed to Accrual - Effective August 16, 2010** 

12/16/2002   07/23/2004  02/09/2013 

RTOG
RTOG-0126 
Lead Group:
RTOG

A Phase III Randomized Study of High Dose 3D-CRT/IMRT versus Standard Dose 3D-CRT/IMRT in Patients Treated for Localized Prostate Cancer (RTOG 0126/Dev. 1077)
** Closed to Accrual – Effective August 20, 2008 ** 

12/17/2001   03/21/2002  09/05/2012 
RTOG-0129 
Lead Group:
RTOG

A Phase III Trial of Concurrent Radiation and Chemotherapy (Followed by Surgery for Residual Primary/N2-3 Nodal Disease)for Advanced Head and Neck Carcinomas
**Closed to Accrual – Effective June 23, 2005** 

06/17/2002   07/30/2002  04/25/2013 
RTOG-0214 
Lead Group:
RTOG

A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients With Locally Advanced Non-Small Cell Lung Cancer
**Closed to Accrual – Effective August 30, 2007** 

05/13/2002   09/19/2002  05/07/2013 
RTOG-0232 
Lead Group:
RTOG

A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy with Brachytherapy Alone for Selected Patients with Intermediate Risk Prostatic Carcinoma
**Closed to Accrual – Effective February 8, 2012** 

12/16/2002   06/11/2003  12/14/2012 
RTOG-0320 
Lead Group:
RTOG

A Phase III Trial Comparing Whole Brain Radiation and Stereotactic Radiosurgery Alone Versus with Temozolomide or Erlotinib in Patients with Non-Small Cell Lung Cancer and 1-3 Brain Metastases
**Closed to Accrual – effective August 11, 2009** 

06/21/2004   10/06/2004  08/24/2012 
RTOG-0412-SWOG-S0332 
Lead Group:
RTOG

Phase III Randomized Trial of Preoperative Chemotherapy Versus Preoperative Concurrent Chemotherapy and Thoracic Radiotherapy Followed by Surgical Resection and Consolidation Chemotherapy in Favorable Prognosis Patients With Stage IIIA (N2) Non-Small Cell Lung Cancer
**Completed (No Further Activity Conducted) – Effective January 2009** 

12/03/2004   04/08/2005   
RTOG-0415 
Lead Group:
RTOG

A Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT versus Conventionally Fractionated 3D-CRT/IMRT in Patients with Favorable-Risk Prostate Cancer
**Closed to Accrual - effective November 6, 2009** 

03/03/2006   04/18/2006  09/05/2012 
RTOG-0421 
Lead Group:
RTOG

A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone.
****ADMINISTRATIVELY COMPLETED as of October 14, 2009** ** 

02/22/2005   04/27/2005   
RTOG-0436 
Lead Group:
RTOG

A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer who are Treated without Surgery
**Temporary Closure to Accrual – Effective June 2, 2011**
**Reactivated to Accrual – Effective July 25, 2011** 

05/21/2007   06/30/2008  12/14/2012 
RTOG-0521 
Lead Group:
RTOG

A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs. AS and 3DCRT/IMRT followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer
**Closed to Accrual – August 21, 2009** 

08/05/2005   12/08/2005  12/05/2012 
RTOG-0522 
Lead Group:
RTOG

A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin and Cetuximab (C225) [Followed by Surgery for Selected Patients] For Stage III and IV Head and Neck Carcinomas
**Closed to Accrual – Effective March 3, 2009** 

08/05/2005   11/22/2005  11/17/2012 
RTOG-0525 
Lead Group:
RTOG

Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose-Intensive Temozolomide in Patients with Newly Diagnosed Glioblastoma
**Closed to Accrual – effective June 13, 2008** 

11/04/2005   01/17/2006  05/09/2013 
RTOG-0534 
Lead Group:
RTOG

A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients with a Rising PSA after Radical Prostatectomy
**Closed to Accrual to Substudy: Health-Related Quality of Life (QOL) - Effective March 22, 2012** 

08/03/2007   02/13/2008  08/17/2012 
RTOG-0617 
Lead Group:
RTOG

A Randomized Phase III Comparison of Standard-Dose (60 Gy) versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer
**Arms B and D Closed to Accrual – Effective June 17, 2011**
**Closure to Accrual – Effective November 22, 2011** 

05/23/2007   11/27/2007  02/28/2013 
RTOG-0724 
Lead Group:
RTOG

Phase III Randomized Study Of Concurrent Chemotherapy And Pelvic Radiation Therapy With Or Without Adjuvant Chemotherapy In High-Risk Patients With Early-Stage Cervical Carcinoma Following Radical Hysterectomy 

08/20/2010   09/16/2009  12/14/2012 
RTOG-0815 
Lead Group:
RTOG

A Phase III Prospective Randomized Trial Of Dose-Escalated Radiotherapy With Or Without Short-Term Androgen Deprivation Therapy For Patients With Intermediate-Risk Prostate Cancer
**Closed to Accrual to Substudy: Health-Related Quality of Life (QOL) - Effective March 22, 2012** 

07/02/2009   09/14/2009  12/14/2012 
RTOG-0825 
Lead Group:
RTOG

Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and AdjuvantTemozolomide plus Bevacizumab versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients with newly Diagnosed Glioblastoma
**Closed to Accrual – Effective May 11, 2011 ** 

12/15/2008   04/15/2009  02/01/2013 
RTOG-0848 
Lead Group:
RTOG

RTOG 0848 A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma 

09/03/2009   11/17/2009  02/01/2013 
RTOG-0920 
Lead Group:
RTOG

A Phase III Study of Postoperative Radiation Therapy (Imrt) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer 

04/20/2009   11/05/2009  09/14/2012 
RTOG-0924 
Lead Group:
RTOG

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial 

06/02/2011   07/07/2011  03/14/2013 
RTOG-1005 
Lead Group:
RTOG

A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer 

05/05/2011   05/24/2011  02/15/2013 
RTOG-1010 
Lead Group:
RTOG

A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma 

08/19/2010   09/29/2010  02/28/2013 
RTOG-1016 
Lead Group:
RTOG

Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer 

02/17/2011   06/09/2011  11/30/2012 
RTOG-1115 
Lead Group:
RTOG

Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GNRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GNRH Agonist and TAK-700 For Men with High Risk Prostate Cancer 

03/01/2012   05/01/2012  02/28/2013 
RTOG-BR-0118 
Lead Group:
RTOG

A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (NSC# 66847) Versus Conventional Radiation Therapy For Multiple Brain Metastases
**Completed (No Further Activity Conducted) - Effective May 1, 2008** 

11/13/2001   02/28/2002   
RTOG-P-0011 
Lead Group:
RTOG
Participating Groups:
CTSU
NCIC CTG

A Phase III Randomized Study of Adjuvant Therapy for High Risk pT3NO Prostate Cancer
**ADMINISTRAVELY COMPLETED as of May 7, 2004** 

04/16/2001   07/13/2001   
RTOG-P-0014 
Lead Group:
RTOG
Participating Groups:
CALGB
CTSU
ECOG
SWOG

A Phase III Randomized Study of Patients With High Risk, Hormone-Naive Prostate Cancer: Androgen Blockade With 4 Cycles of Immediate Chemotherapy Versus Androgen Blockade with Delayed Chemotherapy
**ADMINISTRATIVELY COMPLETED as of February 4, 2005** 

05/21/2001   10/03/2002   

SWOG
S0012 
Lead Group:
SWOG

A Comparative Randomized Study of Standard Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel Vs. Weekly Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel as Neoadjuvant Therapy for Inflammatory and Locally Advanced Breast Cancer
**Closed to Accrual – Effective December 1, 2005,**

**COMPLETED (No Further Activity Being Conducted) as of February 23, 2012** 

03/19/2001   05/01/2001   
S0023 
Lead Group:
SWOG

A Phase III Trial of Cisplatin/Etoposide/ Radiotherapy with Consolidation Docetaxel Followed by Maintenance Therapy with ZD1839 or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
**Closed to Accrual – Effective April 15, 2005**
**COMPLETED (No Further Activity Being Conducted) as of December 9, 2010** 

10/22/2001   06/15/2001   
S0106 
Lead Group:
SWOG

A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) during Induction Therapy Versus Standard Induction with Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy with Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy for Patients Under Age 61 with Previously Untreated De Novo Acute Myeloid Leukemia (AML)
**Closed to Accrual – Effective August 20, 2009** 

05/21/2001   05/15/2004  02/01/2013 
S0124 
Lead Group:
SWOG

Randomized Phase III Trial of Cisplatin (NSC-119875) and Irinotecan (NCSC-616348) Versus Cisplatin and Etoposide (NSC-141540) in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)
**Closed to Accrual - Effective March 1, 2007**
**COMPLETED (No Further Activity is being Conducted), as of July 22, 2010** 

02/19/2002   11/01/2002   
S0200 
Lead Group:
SWOG

A Phase III Randomized Study of Pegylated Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian or Peritoneal Carcinoma After Failure of Initial Platinum-Based Chemotherapy
**Closed to Accrual – Effective December 15, 2005**
**COMPLETED (No Further Activity Being Conducted) as of August 23, 2011** 

05/13/2002   08/15/2002   
S0205 
Lead Group:
SWOG

A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer
**Closed to Accrual – Effective April 1, 2006**
**COMPLETED (No Further Activity Being Conducted) as of August 30, 2011** 

09/15/2003   01/01/2004   
S0221 
Lead Group:
SWOG

Phase III Trial of Continuous Schedule AC+G Vs. Q2Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer
** Suspension of Accrual – Effective November 10, 2010**
** Reactivation of Accrual – Effective December 15, 2010**
**Closed to Accrual – Effective January 15, 2012** 

07/21/2003   11/01/2003  09/14/2012 
S0226 
Lead Group:
SWOG

Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women with Metastatic Breast Cancer
**The pharmacokinetic (PK) component (see Section 15.5) for SWOG S0226 has been permanently closed effective April 16, 2009**
**Closed to Accrual – Effective July 1, 2009** 

09/15/2003   04/01/2004  12/14/2012 
S0227 
Lead Group:
SWOG
Participating Groups:
CTSU

Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix
**COMPLETED (No Further Activity Conducted) - Effective July 28, 2003** 

12/16/2002   04/01/2003   
S0232 
Lead Group:
SWOG

Double-Blinded Placebo Controlled Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients with Previously Untreated Multiple Myeloma who are Not Immediately Undergoing Autologous Stem Cell Transplant
**Closed to Accrual – Effective May 11, 2007** 

03/17/2003   11/01/2004  10/30/2012 
S0303 
Lead Group:
SWOG
Participating Groups:
SWOG

A Phase III Study of FOLFOX6 versus CapOX, with Bevacizumab (NSC-704865) or Placebo, as First-Line Therapy in Patients with Previously Untreated Metastatic Colorectal Cancer
**ADMINISTRATIVELY COMPLETED as of 1/1/07** 

07/21/2003   04/01/2004   
S0307 
Lead Group:
SWOG

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
**Closed to Accrual – effective February 1, 2010** 

05/16/2005   11/15/2005  04/04/2013 
S0309 
Lead Group:
SWOG

Myeloma Specimen Repository Protocol Ancillary
**Closed to Accrual – Effective November 1, 2010**
**COMPLETED (No Further Activity Being Conducted) as of June 13, 2011** 

12/03/2004   11/15/2003   
S0334 
Lead Group:
SWOG
Participating Groups:
SWOG

"Cytogenetic and Fluorescence In Situ Hybridization Studies in Multiple Myeloma"

**COMPLETED (No Further Activity Being Conducted) as of June 15, 2007 **  

06/02/2006   09/01/2005   
S0337 
Lead Group:
SWOG

A Phase III Blinded Study Of Immediate Post TURBT Instillation Of Gemcitabine Versus Saline In Patients With Newly Diagnosed Or Occasionally Recurring Grade I/II Superficial Bladder Cancer 

09/01/2006   07/15/2007  05/02/2013 
S0347 
Lead Group:
SWOG
Participating Groups:
CTSU
SWOG

A Randomized Study of Weekly Vinorelbine (Navelbine) Alone or in Combination with Trastuzumab (Herceptin) (NSC-688097) for Patients With HER-2-Positive Metastatic Breast Cancer Whose Tumors Have Progressed After Taxane and Trastuzumab Combination Therapy - Phase III
**COMPLETED (No Further Activity Being Conducted) as of February 1, 2006** 

09/20/2004   12/15/2004   
S0421 
Lead Group:
SWOG

Phase III Study Of Docetaxel And Atrasentan Versus Docetaxel And Placebo For Patients With Advanced Hormone Refractory Prostate Cancer.
**Closed to Accrual – effective May 1, 2010** 

05/16/2005   08/21/2006  10/27/2012 
S0427 
Lead Group:
SWOG

A Phase III Trial of Standard Fractionation Radiation and Concurrent Single Agent Cisplatin, With and Without Docetaxel, Cisplatin, and 5-Fluorouracil Induction Chemotherapy, in Patients with Advanced Oropharyngeal Squamous Cell Cancer

**ADMINISTRATIVELY COMPLETED - Effective December 17, 2007** 

09/19/2005   12/15/2005   
S0500 
Lead Group:
SWOG

A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment

**Closed to Accrual – Effective March 15, 2012** 

06/19/2006   10/01/2006  12/14/2012 
S0502 
Lead Group:
SWOG

A Phase III Randomized Study of Imatinib, with or without Bevacizumab (NSC-704865), in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors
**Closed to Accrual - Effective October 1, 2009** 

11/04/2005   04/15/2008  08/31/2012 
S0518 
Lead Group:
SWOG

Phase III Prospective Randomized Comparison of Depot Octreotide plus interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC 704865) in Advance, Poor Prognosis Carcinoid Patients 

08/21/2006   12/01/2007  02/01/2013 
S0521 
Lead Group:
SWOG

A Randomized Trial of Maintenance versus Observation for Patients with Previously Untreated Low and Intermediate Risk Acute Promyelocytic Leukemia (APL), Phase III
**Closed to Accrual - Effective May 27, 2010** 

06/02/2006   06/01/2007  09/14/2012 
S0600 
Lead Group:
SWOG

Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) or Bevacizumab (NSC-704865) as Second-Line Therapy for Patients with Metastatic Colorectal Cancer who have Progressed on Bevacizumab with either FOLFOX, OPTIMOX or XELOX
**Suspension of Accrual - effective June 6, 2008**

**Reactivation of Accrual - effective October 15, 2009**

**Closed to Accrual – Effective November 10, 2010** 

08/04/2006   06/15/2007  03/14/2013 
S0777 
Lead Group:
SWOG

A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant
**Study is Re-Activated and open to enrollment as of July 1, 2008**
**Closed to Accrual – Effective February 1, 2012** 

11/19/2007   04/01/2008  02/01/2013 
S0819 
Lead Group:
SWOG

A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab In Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) 

07/16/2009   08/05/2009  11/30/2012 
S0931 
Lead Group:
SWOG

EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study 

03/18/2010   04/01/2011  05/16/2013 
S1007 
Lead Group:
SWOG

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less 

12/02/2010   01/15/2011  09/14/2012 
S1011 
Lead Group:
SWOG

A Phase III Surgical Trial to Evaluate the Benefit of a Standard Versus an Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy for Muscle Invasive Urothelial Cancer 

10/07/2010   07/07/2011  04/18/2013 
S9910 
Lead Group:
SWOG

Leukemia Centralized Reference Laboratories and Tissue Repositories Ancillary
**Closed to Accrual – Effective January 1, 2012**

**COMPLETED (No Further Activity Being Conducted) as of April 18, 2012** 

05/21/2001   04/15/1999   
S9925 
Lead Group:
SWOG

Lung Cancer Specimen Repository Protocol Ancillary
**Closed to Accrual – effective March 15, 2010**
**COMPLETED (No Further Activity is being Conducted), as of September 27, 2010** 

05/21/2001   09/01/2000   
SWOG-9007 
Lead Group:
SWOG

Cytogenetic Studies in Leukemia Patients
**Closed to Accrual – Effective January 1, 2012**

**COMPLETED (No Further Activity Being Conducted) as of April 18, 2012** 

05/21/2001   07/15/1991   
     
   
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