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CIRB Approved Protocols

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Protocol # Protocol Title CIRB Initial Review Date Group Activation Date Expiration Date
ACOSOG-Z1031 
Lead Group:
ACOSOG
Participating Groups:
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." 

7/19/2004  1/9/2006  7/4/2008 
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 Palpable and Operable Breast Cancer" 

12/1/2006  7/2/2007  11/1/2008 
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  

4/19/2004  7/15/2005  5/1/2009 
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** 

4/19/2004  8/23/2004   
CALGB-100104-ECOG 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 

6/21/2004  12/15/2004  5/1/2009 
CALGB-10201 
Lead Group:
CALGB
Participating Groups:
CTSU

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
**Permanently Closed to New Patient Accrual - Effective Friday, October 20, 2006 at 5pm ET** 

9/15/2003  12/15/2003  1/13/2009 
CALGB-10501 
Lead Group:
CALGB

A Phase III Intergroup CLL Study of Asymptomatic Patients with Untreated Chronic Lymphocytic Leukemia Patients Randomized to Early Intervention Versus Observation with Later Treatment in the High Risk Genetic Subset with IgVh Unmutated Disease 

3/19/2007  1/15/2008  2/18/2009 
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 # TBD) or Placebo in Newly Diagnosed Patients < 60 Years of Age with FLT3 Mutated Acute Myeloid Leukemia (AML) 

2/22/2008  4/1/2008  2/21/2009 
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 

2/12/2007  6/15/2007  12/6/2008 
CALGB-30102 
Lead Group:
CALGB
Participating Groups:
CTSU
SWOG

Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)
**Closed to Accrual by CALGB - Effective December 28, 2004 at 5pm ET**  

1/22/2002  5/15/2002  1/22/2009 
CALGB-30610 
Lead Group:
CALGB

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

11/11/2007  3/21/2008  1/31/2009 
CALGB-40101 
Lead Group:
CALGB
Participating Groups:
CTSU
ECOG
NCCTG
SWOG

Cyclophosphamide and Doxorubicin (Ca) (4 Vs 6 Cycles) Versus Paclitaxel (4 Vs 6 Cycles) as Adjuvant Therapy for Women with 0-3 Positive Axillary Lymph Nodes: A 2x2 Factorial Phase III Study 

4/15/2002  5/15/2002  7/5/2008 
CALGB-40302 
Lead Group:
CALGB
Participating Groups:
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" 

2/20/2001  9/15/2006  10/4/2008 
CALGB-49907 
Lead Group:
CALGB
Participating Groups:
CTSU
ECOG
NCCTG
NCIC-CTG
SWOG

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 Node Negative Stage Breast Cancer
**Permanently Closed to New Patient Accrual - Effective Friday, December 29, 2006 at 5pm ET** 

8/20/2001  9/15/2001  2/21/2009 
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  5/2/2005  9/6/2008 
CALGB-70301 
Lead Group:
CALGB
Participating Groups:
CALGB

"Quality of Life, Employment and informal Care Cost Analysis in Women Receiving Adjuvant Chemotherapy for Node-Negative Breast Cancer: Companion to 40101" 

6/20/2005  10/15/2005  11/18/2008 
CALGB-80101 
Lead Group:
CALGB
Participating Groups:
CTSU
ECOG
NCCTG
NCIC-CTG
RTOG
SWOG

A Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma 

8/19/2002  12/15/2002  4/20/2009 
CALGB-80203 
Lead Group:
CALGB
Participating Groups:
CTSU

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** 

8/18/2003  12/15/2003  8/2/2008 
CALGB-80303 
Lead Group:
CALGB
Participating Groups:
CTSU

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 by CALGB - Effective April 14, 2006 at 5pm ET**  

4/19/2004  6/15/2004  8/2/2008 
CALGB-90104 
Lead Group:
CALGB
Participating Groups:
CTSU
ECOG

A Randomized Phase III Study Comparing Sequential Chemotherapy (AG-TP) to Cisplatin and Gemcitabine as Adjuvant Treatment after Cyctectomy for Transitional Cell Carcinoma of the Bladder
**Closed to Accrual by CALGB on July 15, 2005** 

6/16/2003  3/15/2004  8/23/2008 
CALGB-90202 
Lead Group:
CALGB
Participating Groups:
CTSU

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. 

4/14/2003  1/15/2004  8/2/2008 
CALGB-90203 
Lead Group:
CALGB
Participating Groups:
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" 

10/6/2005  12/15/2006  8/2/2008 
CALGB-90206 
Lead Group:
CALGB
Participating Groups:
CTSU
ECOG
NCIC CTG

A Randomized Phase III Trial of Interferon Alfa-2B or Interferon Alfa-2B Plus Bevacizumab in Patients with Advanced Renal Carcinoma
**Will be Permanently Closed to New Patient Accrual Effective Friday, July 1, 2005, at 5:00 pm ET** 

6/16/2003  10/1/2003  9/5/2008 
CALGB-90401 
Lead Group:
CALGB
Participating Groups:
CTSU

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 Patient Accrual - Effective December 21, 2007 at 5pm EST**  

10/18/2004  4/15/2005  8/2/2008 
CALGB-SWOG-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" 

6/20/2005  9/15/2005  12/6/2008 
COG-AALL0331 
Lead Group:
COG

Standard Risk B-precursor Acute Lymphoblastic Leukemia
**Temporarily Closed to Accrual by COG - Effective May 2, 2008** 

1/13/2005  4/11/2005  7/11/2008 
COG-AALL03B1 
Lead Group:
COG
Participating Groups:
COG

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

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

1/13/2005  12/29/2003  7/11/2008 
COG-AALL03N1 
Lead Group:
COG
Participating Groups:
COG

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

11/22/2004  5/30/2005  10/10/2008 
COG-AALL0433 
Lead Group:
COG

"Intensive Treatment For Intermediate-Risk Relapse Of Childhood B-Precursor Acute Lymphoblastic Leukemia (All): A Randomized Trial Of Vincristine Strategies" 

1/26/2006  3/26/2007  9/26/2008 
COG-AALL0434 
Lead Group:
COG
Participating Groups:
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"
**Temporarily Closed to Accrual by COG - Effective May 2, 2008**

**Enrollment Suspended for Patients with Down Syndrome by COG - Effective February 20, 2008**  

2/23/2006  1/15/2007  8/22/2008 
COG-AALL05B1 
Lead Group:
COG

"A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens." 

4/13/2006  9/25/2006  4/9/2009 
COG-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) 

7/12/2007  1/14/2008  7/11/2008 
COG-AALL06N1 
Lead Group:
COG
Participating Groups:
COG

A Study of Neurocognitive Function in Children Treated for ALL. **Temporary Closure - Effective April 3, 2008 ** 

10/26/2006  1/29/2007  8/22/2008 
COG-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." 

1/26/2006  3/26/2007  2/13/2009 
COG-AAML0523 
Lead Group:
COG

"A Phase II Study of CLOLAR® (Clofarabine, IND# 73,789) in Combination with Cytarabine in Pediatric Patients with Refractory/Relapsed Leukemia." **Temporary Closure - Effective March 28, 2008 ** 

4/13/2006  3/12/2007  11/7/2008 
COG-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" 

2/23/2006  8/14/2006  9/26/2008 
COG-AAML05P1 
Lead Group:
COG

Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Cell Transplantation (HCT) for Refractory and Relapsed Acute Myelogenous Leukemia (AML) and newly diagnosed AML with monosomy 7 or -5/5qin Children 

3/8/2007  1/21/2008  12/20/2008 
COG-AAML06P1 
Lead Group:
COG

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

12/14/2006  6/11/2007  12/12/2008 
COG-AAML07P1 
Lead Group:
COG
Participating Groups:
COG

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

11/8/2007  4/21/2008  11/7/2008 
COG-ABTR04B1 
Lead Group:
COG

"Establishing Continuous Cell Lines and Xenografts from Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies" 

1/26/2006  3/5/2007  9/26/2008 
COG-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) 

11/22/2004  12/12/2005  8/8/2008 
COG-ACCL05C1 
Lead Group:
COG

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

6/22/2006  2/5/2007  12/12/2008 
COG-ACCL0631 
Lead Group:
COG

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

5/10/2007  3/24/2008  8/22/2008 
COG-ACCRN07 
Lead Group:
COG

Childhood Cancer Research Network: Protocol for Registration and Consent Procedures of the Children's Oncology Group 

3/8/2007  12/24/2007  8/22/2008 
COG-ACNS0221 
Lead Group:
COG

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

3/10/2005  11/28/2005  8/8/2008 
COG-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." 

4/24/2006  6/4/2007  12/12/2008 
COG-ACNS0232 
Lead Group:
COG
Participating Groups:
COG

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

9/8/2005  1/29/2007  3/12/2009 
COG-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." 

4/24/2006  3/26/2007  1/9/2009 
COG-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" 

1/26/2006  7/24/2007  9/9/2008 
COG-ACNS0423 
Lead Group:
COG
Participating Groups:
COG

A Phase II Study of Concurrent Radiation and Temozolomide Followed by Temozolomide and CCNU in the Treatment of Children with High Grade Glioma **Closed to Accrual by COG - Effective October 26, 2007**  

1/13/2005  3/21/2005  7/11/2008 
COG-ADVL0221 
Lead Group:
COG

"A Phase II Study of ET-743 in Children with Recurrent Sarcomas"  

2/24/2005  1/28/2008  1/20/2009 
COG-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  4/24/2006  9/26/2008 
COG-ADVL0525 
Lead Group:
COG

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

10/12/2006  9/3/2007  7/16/2008 
COG-ADVL06B1 
Lead Group:
COG

A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children with Cancer - A Groupwide Non-Therapeutic Study 

4/12/2007  2/11/2008  2/24/2009 
COG-AEWS0521 
Lead Group:
COG
Participating Groups:
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 

11/9/2006  2/25/2008  9/9/2008 
COG-AEWS0531 
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." 

1/12/2006  2/25/2008  9/9/2008 
COG-AEWS0621 
Lead Group:
COG
Participating Groups:
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** 

10/12/2006  5/7/2007  7/10/2008 
COG-AEWS07B1 
Lead Group:
COG

A COG Study for Collecting and Banking Ewing Sarcoma Specimens 

6/14/2007  2/4/2008  3/10/2009 
COG-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 

8/9/2007  3/9/2008  8/8/2008 
COG-AGCT0521 
Lead Group:
COG

Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors with Paclitaxel, Ifosfamide and Carboplatin 

11/30/2006  11/5/2007  10/15/2008 
COG-AHOD03P1 
Lead Group:
COG

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

3/10/2005  1/2/2006  8/8/2008 
COG-AHOD0431 
Lead Group:
COG

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

4/28/2005  2/13/2006  8/22/2008 
COG-AHOD04B1 
Lead Group:
COG
Participating Groups:
COG

"Hodgkin Disease (HD) Banking Study" 

6/8/2006  10/23/2006  2/13/2009 
COG-AHOD0521 
Lead Group:
COG
Participating Groups:
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 

6/22/2006  1/16/2007  2/13/2009 
COG-ANBL00B1 
Lead Group:
COG

Neuroblastoma Biology Studies 

1/27/2005  10/25/2005  7/11/2008 
COG-ANBL00P3 
Lead Group:
COG

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

1/27/2005  9/21/2005  10/10/2008 
COG-ANBL0421 
Lead Group:
COG

"A Phase II Study of Irinotecan + Temozolomide in Children with Recurrent Neuroblastoma"
**Stratum 1 Closed to Enrollment by COG - Effective April 11, 2008** 

7/14/2005  4/24/2006  4/9/2009 
COG-ANBL0531 
Lead Group:
COG
Participating Groups:
COG

"Response and Biology-Based Therapy for Intermediate-Risk Neuroblastoma." 

11/30/2006  10/8/2007  1/9/2009 
COG-ANBL0532 
Lead Group:
COG

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

3/8/2007  11/5/2007  1/9/2009 
COG-ANHL04B1 
Lead Group:
COG

Rare and Cutaneous Non-Hodgkin Lymphoma Registry 

1/13/2005  5/30/2005  7/11/2008 
COG-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 

1/27/2005  11/14/2005  7/11/2008 
COG-AOST06B1 
Lead Group:
COG

¿A Children's Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens¿ 

12/28/2006  2/4/2008  10/11/2008 
COG-ARAR0331 
Lead Group:
COG

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

3/10/2005  2/20/2006  8/8/2008 
COG-ARAR0332 
Lead Group:
COG
Participating Groups:
COG

"Treatment of Adrenocortical Tumors with Surgery plus Lymph Node Dissection and Multiagent Chemotherapy; A Groupwide Phase III Study" 

3/10/2005  9/18/2006  12/12/2008 
COG-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**  

7/28/2005  6/19/2006  8/22/2008 
COG-AREN03B2 
Lead Group:
COG

"Renal Tumors Classification, Biology, and Banking Study" 

7/28/2005  2/27/2006  1/9/2009 
COG-AREN0532 
Lead Group:
COG
Participating Groups:
COG

"Treatment for Very Low, Low and Standard Risk Favorable Histology Wilms Tumor." 

4/13/2006  10/30/2006  11/7/2008 
COG-AREN0533 
Lead Group:
COG

"Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumor" 

4/13/2006  2/26/2007  12/12/2008 
COG-ARET0231 
Lead Group:
COG

A Single Arm Trial of Systemic and Subtenon Chemotherapy for Groups C and D Intraocular Retinoblastoma: A Phase III Limited Institution Study 

10/6/2005  4/16/2007  1/9/2009 
COG-ARET0321 
Lead Group:
COG

"A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma." 

1/12/2006  2/4/2008  1/20/2009 
COG-ARET0331 
Lead Group:
COG

"Trial of systemic neoadjuvant chemotherapy for Group B intraocular retinoblastoma; A Phase III Limited Institution Study" 

2/10/2005  12/26/2005  8/8/2008 
COG-ARET0332 
Lead Group:
COG

"Adjuvant Therapy for Patients with Unilateral Retinoblastoma with High Risk Features on Histopathologic Examination; A Groupwide Phase III Study " 

2/24/2005  12/12/2005  8/22/2008 
COG-ARST0332 
Lead Group:
COG
Participating Groups:
COG

"Risk-Based Treatment for Pediatric Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS): A Groupwide Phase III Study 

3/23/2006  2/5/2007  10/10/2008 
COG-ARST03P1 
Lead Group:
COG

"A Pilot Phase II Study for Children with Infantile Fibrosarcoma; A Groupwide Phase II Study"
**Closed to Accrual - Effective January 19, 2007 at 5 PM ET** 

2/24/2005  7/22/2005  3/16/2009 
COG-ARST0431 
Lead Group:
COG
Participating Groups:
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 March 17, 2008 5 p.m. EST** 

12/8/2005  7/17/2006  7/12/2008 
COG-ARST0531 
Lead Group:
COG
Participating Groups:
COG

Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS) 

1/12/2006  12/26/2006  8/8/2008 
COG-ASCT0431 
Lead Group:
COG

"A Randomized Trial of Sirolimus-Based Graft versus Host Disease Prophylaxis After Hematopoietic Stem Cell Transplantation in Relapsed ALL" 

3/23/2006  3/19/2007  1/9/2009 
COG-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." 

10/26/2006  12/31/2007  3/31/2009 
COG-D9902 
Lead Group:
COG

"A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol." 

12/8/2005  2/20/2006  7/11/2008 
ECOG-E1105 
Lead Group:
ECOG
Participating Groups:
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" 

3/13/2007  11/9/2007  9/6/2008 
ECOG-E1301 
Lead Group:
ECOG
Participating Groups:
ACOSOG
CTSU
NCIC CTG

A Phase III Randomized study of Adjuvant Biologic Therapy in Patients with Stages III/IV Head and Neck Squamous Cell Carcinoma
**Closed to Accrual - Effective December 20, 2004 at 5pm ET** 

5/13/2002  2/21/2003  8/16/2008 
ECOG-E1302 
Lead Group:
ECOG

Phase III Randomized, Placebo-Controlled Trial of Docetaxel Versus Docetaxel Plus Zd1839 ("Iressa") 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** 

2/9/2004  8/6/2004  7/15/2008 
ECOG-E1505 
Lead Group:
ECOG

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

1/23/2006  6/1/2007  9/6/2008 
ECOG-E1899 
Lead Group:
ECOG
Participating Groups:
CALGB
CTSU
SWOG

A 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 at 5pm ET**  

7/15/2002  10/31/2002  10/4/2008 
ECOG-E1900 
Lead Group:
ECOG
Participating Groups:
CTSU

A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification and Gemtuzumab-Ozogamicin Consolidation Therapy Prior to Autologous Stem Cell Transplantation
**Accrual Suspended as of Feb 1, 2008 - No new patients should be enrolled into this study** **RE-OPENED TO ACCRUAL, as of April 29, 2008**  

3/18/2002  12/16/2002  10/31/2008 
ECOG-E1A00 
Lead Group:
ECOG
Participating Groups:
CTSU

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** 

11/13/2001  4/17/2002  11/5/2008 
ECOG-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 2ith Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen" 

2/12/2007  9/6/2007  3/16/2009 
ECOG-E1A06 
Lead Group:
ECOG

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

4/6/2007  2/29/2008  3/23/2009 
ECOG-E1Y03 
Lead Group:
ECOG

Master Protocol for Pharmacogenetic and Genomic Studies
 

2/22/2005  9/15/2004  11/6/2008 
ECOG-E2100 
Lead Group:
ECOG
Participating Groups:
CALGB
CTSU
NCCTG
NCIC CTG
NSABP
SWOG

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** 

8/20/2001  12/21/2001  9/6/2008 
ECOG-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 5:00 pm EST on May 26, 2006** 

9/17/2002  3/27/2003  1/3/2009 
ECOG-E2603 
Lead Group:
ECOG
Participating Groups:
ECOG

A Double-Blind, Randomized, Placebo-Controlled Phase III Trial Of Carboplatin, Paclitaxel And Bay 43-9006 Versus Carboplatin, Paclitaxel And Placebo In Patients With Unresectable Locally Advanced Or Stage IV Melanoma
**CLOSED TO ACCRUAL - Effective 5:00 pm EST on Tuesday, April 22, 2008** 

9/13/2004  6/23/2005  4/3/2009 
ECOG-E2805 
Lead Group:
ECOG
Participating Groups:
ECOG

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable REnal Carcinoma 

12/19/2005  4/24/2006  8/2/2008 
ECOG-E2902 
Lead Group:
ECOG
Participating Groups:
CTSU
SWOG

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
**CTSU Re-Activation Date: 2/7/08** 

11/17/2003  8/18/2004  12/6/2008 
ECOG-E3200 
Lead Group:
ECOG
Participating Groups:
CTSU

Phase III Trial of Bevacizumab, Oxaliplatin, Fluorouracil and Leucovorin versus Oxaliplatin, Fluorouracil and Leucovorin versus Bevacizumab Alone in Previously Treated Patients with Advanced Colorectal Cancer
**Closed to Accrual - Effective April 28, 2003 at 5pm ET** 

7/16/2001  10/30/2001  9/6/2008 
ECOG-E3201 
Lead Group:
ECOG
Participating Groups:
CALGB
CTSU
NCCTG
NSABP
SWOG

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 -Fluorouracil or Postoperative Radiation and 5-Fluorouracil
**Accrual Closed Effective November 1, 2005**  

2/17/2003  10/15/2003  1/13/2009 
ECOG-E3805 
Lead Group:
ECOG
Participating Groups:
ECOG

"CHAARTED: ChemHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer" 

7/18/2005  7/28/2006  9/16/2008 
ECOG-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

**Study closed to accrual 09/15/05**

**ECOG has Discontinued Activation of any New Sites to this Study - Effective Immediately (4/19/05) **  

5/13/2002  7/17/2002  8/2/2008 
ECOG-E4201 
Lead Group:
ECOG
Participating Groups:
CTSU
NCCTG
NCIC CTG
RTOG

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 on December 15, 2005** 

11/12/2002  4/10/2003  10/11/2008 
ECOG-E4402 
Lead Group:
ECOG
Participating Groups:
CTSU

Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens for Low Tumor Burden Patients with Indolent non-Hodgkin's Lymphoma 

7/21/2003  11/21/2003  9/6/2008 
ECOG-E4599 
Lead Group:
ECOG
Participating Groups:
CALGB
CTSU

A Randomized Phase II/III Trial of Paclitaxel plus Carboplatin with or without Bevacizumab (NSC #704865) in Patients with Advanced Non-squamous NSCLC
**Study Closed to accrual by ECOG, Patients still on treatment - Effective 5:00pm EST April 7, 2004 ** 

6/18/2001  7/19/2001  8/19/2008 
ECOG-E4A03 
Lead Group:
ECOG
Participating Groups:
CTSU

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
**Closed to Accrual by ECOG - Effective June 1, 2007 at 5pm ET**  

5/17/2004  10/26/2004  9/6/2008 
ECOG-E5103 
Lead Group:
ECOG
Participating Groups:
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" 

8/21/2006  11/2/2007  2/21/2009 
ECOG-E5202 
Lead Group:
ECOG
Participating Groups:
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 

9/20/2004  8/4/2005  1/31/2009 
ECOG-E5204 
Lead Group:
ECOG
Participating Groups:
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 

12/2/2005  2/17/2006  4/3/2009 
ECOG-E6201 
Lead Group:
ECOG
Participating Groups:
CALGB
CTSU
NCCTG

A Phase III, Randomized Study of Gemcitabine [fixed-dose rate infusion] and Oxaliplatin versus Gemcitabine [fixed-dose rate infusion] versus Gemcitabine [30-minute infusion] in Pancreatic Carcinoma
**Closed to Accrual - Effective March 16, 2005 5:00 pm EST**  

9/17/2002  2/22/2003  9/16/2008 
ECOG-PACCT-1 
Lead Group:
ECOG
Participating Groups:
ECOG

"Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The Tailor Rx Trial" 

11/21/2005  4/7/2006  9/6/2008 
GOG-0198 
Lead Group:
GOG
Participating Groups:
CTSU

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 30, 2007 at 5:00pm EST** 

3/18/2002  2/3/2003  7/15/2008 
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 at 5:00pm EST** 

3/17/2003  5/27/2003  7/5/2008 
GOG-0209 
Lead Group:
GOG
Participating Groups:
CTSU

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** 

3/17/2003  8/25/2003  11/18/2008 
GOG-0212 
Lead Group:
GOG

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

1/7/2005  3/21/2005  8/2/2008 
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 #7921) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer 

6/1/2007  12/6/2007  8/2/2008 
GOG-0218 
Lead Group:
GOG

A Phase III Trial Of Carboplatin And Paclitaxel Plus Placebo Versus Carboplatin And Pac