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**
**Re-Open to Accrual – Effective October 1, 2009** 

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 

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** 

A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED RESECTION VERSUS OPEN RESECTION FOR RECTAL CANCER 

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** 

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** 

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** 

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** 

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)  

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

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** 

A Randomized Phase III Trial of Adjuvant Therapy in Early Stage Non-Small Cell Lung Cancer Evaluating the Potential Utility of a Genomic Prognostic Model to Identify Patients as Candidates for Adjuvant Chemotherapy 

Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #74019, 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 

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

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 

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 

A RANDOMIZED PHASE III TRIAL OF WEEKLY PACLITAXEL COMPARED TO WEEKLY NANOPARTICLE ALBUMIN BOUND NAB-PACLITAXEL OR IXABEPILONE COMBINED WITH BEVACIZUMAB AS FIRST -LINE THERAPY FOR LOCALLY RECURRENT OR METASTATIC BREAST CANCER 

Endocrine Therapy in Combination with ANTI-VEGF Therapy: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865; IND 7921) for Women with Hormone Receptorpositive Advanced Breast Cancer 

Randomized Phase III Trial of Paclitaxel combined with Trastuzumab, Lapatinib, or Both as Neoadjuvant Treatment of HER2-Positive Primary Breast Cancer 

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** 

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** 

Phase III Randomized Study of R-Chop vs. Dose-Adjusted Epoch-R with Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas 

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 

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

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** 

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** 

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.**  

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** 

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** 

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 

A Randomized Phase III Study Of Ne0-Adjuvant Docetaxel And Androgen Deprivation Prior To Radical Prostatectomy Versus Immediate Radical Prostatectomy In Patients With High-Risk, Clinically Localized Prostate Cancer 

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** 

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** 

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

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 

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** 

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 

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 at 5pm ET**
**COMPLETED (No Further Activity Being Conducted) as of November 25, 2009** 

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**  

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

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) 

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** 

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 1, 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** 

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**  

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

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 

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

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** 

Randomized Phase III Trial of Rituximab and Autologous Stem Cell Transplantation for B Cell Diffuse Large Cell Lymphoma
**Closed to Accrual – Effective May 26, 2006** 

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** 

ASSURE: Adjuvant Sorafenib or Sunitib for Unfavorable Renal Carcinoma 

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** 

A Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimidฎ) Alone and in Combination with Epoetin Alfa (Procritฎ) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia 

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
**COMPLETED (No Further Activity Being Conducted) as of April 20, 2007** 

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** 

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

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** 

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

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** 

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 ** 

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** 

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 - Effective June 1, 2007** 

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** 

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** 

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

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
**COMPLETED (No Further Activity Being Conducted) as of February 4, 2008**  

Program For The Assessment of Clinical Cancer Test (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial 

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** 

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** 

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** 

Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF Versus Carboplatin/Paclitaxel in Patients with Stage III and 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** 

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

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 

A Phase III Trial Of Carboplatin And Paclitaxel Plus Placebo Versus Carboplatin And Paclitaxel Plus Concurrent Bevacizumab (NSC #704865, IND #7921) 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** 

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** 

A Randomized Phase III Trial of Cisplatin plus Paclitaxel with and without NCI-Supplied Bevacizumab (NSC #704865, IND #7921) Versus the Non-Platinum Doublet, Topotecan Plus Paclitaxel, with and without NCI supplied Bevacizumab, in Stage IVB, Recurrent or Persistent Carcinoma of the Cervix 

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 

A Randomized Phase III Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF with Bevacizumab (NSC #704865, IND #7921) 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 #7921) 

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 #7921) 

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  

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

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
**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** 

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** 

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

Phase III Intergroup Study of Radiotherapy versusTemozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide forPatients with 1p/19q Codeleted Anaplastic Glioma 

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** 

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** 

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** 

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** 

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** 

A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer (START) 

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**  

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 ** 

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** 

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** 

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** 

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** 

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 

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** 

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 

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** 

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** 

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 

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 ** 

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** 

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** 

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 

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** 

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** 

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** 

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** ** 

A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer who are Treated without Surgery 

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** 

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** 

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

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 

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 

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 

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 

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 

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

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

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** 

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

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** 

Cytogenetic Studies in Leukemia Patients 

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,** 

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** 

A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotargฎ) during Induction Therapy Versus Standard Induction with Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy with Gemtuzumab Ozogamicin (Mylotargฎ) 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** 

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** 

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, 2004** 

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** 

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 

Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First-Line Therapy for Postmenopausal 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** 

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** 

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** 

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** 

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

Myeloma Specimen Repository Protocol Ancillary 

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

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

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 

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** 

Phase III Study Of Docetaxel And Atrasentan Versus Docetaxel And Placebo For Patients With Advanced Hormone Refractory Prostate Cancer. 

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** 

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 

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** 

Phase III Prospective Randomized Comparison of Depot Octreotide plus interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC 704865) in Advance, Poor Prognosis Carcinoid Patients
**Temporary Closure to Step 2 (SPECT Substudy) - effective January 22, 2010** 

A Randomized Trial of Maintenance versus Observation for Patients with Previously Untreated Low and Intermediate Risk Acute Promyelocytic Leukemia (APL), Phase III 

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** 

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** 

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) 

Leukemia Centralized Reference Laboratories and Tissue Repositories Ancillary 

Lung Cancer Specimen Repository Protocol Ancillary