Trial & Business Updates:

Printer Friendly Version

Priority Lists

Activations

S0329Phase II
Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Coordinator(s)Omer Kucuk, M.D., Richard H. Wheeler, M.D., Francis P. Worden, M.D.
ParticipantsMembers, NCORP, Medical Oncologists

Closures

E8897Intergroup

Permanent Closure

Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology with Outcome in Early Stage Nonseminomatous Germ Cell Tumor
Study Coordinator(s)Craig R. Nichols, M.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Radiation Oncologists, Pathologists
Closure Date2004-12-28
S0211Phase II

Temporary Closure

A Phase II Trial of STI571 for the Treatment of Platinum and Taxane Refractory Stage III and IV Epithelial Ovarian Cancer and Primary Peritoneal Cancer
Study Coordinator(s)Andy Jang, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists
Closure Date2006-01-01

Amendments, Revisions, Memoranda

N9831Phase III Intergroup

Amendment #7

Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer
Study Coordinator(s)Silvana Martino, D.O.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons
R9704Phase III

Revision #4

A Phase III Study of Pre and Post Chemoradiation 5-FU vs. Pre and Post Chemoradiation Gemcitabine for Postoperative Adjuvant Treatment of Resected Pancreatic Adenocarcinoma
Study Coordinator(s)John S. Macdonald, M.D.
ParticipantsMembers, Surgeons, Radiation Oncologists, NCORP
R9811Phase III Intergroup

Revision #6

Phase III Study of 5-Fluorouracil, Mitomycin-C, and Radiotherapy Versus 5-Fluorouracil, Cisplatin and Radiotherapy in Carcinoma of the Anal Canal
Study Coordinator(s)Charles R. Thomas Jr., M.D., Kevin G. Billingsley, M.D.
ParticipantsNCORP, Members, Surgeons, Radiation Oncologists
RTOG 0212Phase II-III Intergroup

Amendment #1

A Phase II/III Randomized Trial of Two Doses (Phase III-Standard vs. High) and Two High Doe Schedules (Phase II-Once vs. Twice Daily) for Delivering Prophylactic Cranial Irradiation for Patients with Limited Disease Small Cell Lung Cancer
Study Coordinator(s)Zelanna Goldberg, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists
S0124Phase III

Memorandum

Randomized Phase III Trial of Cisplatin and Irinotecan versus Cisplatin and Etoposide in Patients with Extensive Stage Small Cell Lung Cancer
Study Coordinator(s)Ronald B. Natale, M.D., David R. Gandara, M.D., Primo N. Lara, Jr., M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S0200Phase III

Memorandum

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
Study Coordinator(s)Ana Maria Lopez, M.D., M.Ph, Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU Institutions in the United States
S0205Phase III

Memorandum

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
Action CodesER
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph Wong, M.D., Nancy Vaught, R.N.,O.C.N
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0213Phase II Pilot

Revision #5

Pilot Trial of Hyper-CVAD and Methotrexate/ARA C+ Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
Study Coordinator(s)Elliot M. Epner, M.D., Ph.D, Thomas P. Miller, M.D., Catherine Spier, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0222Phase II

Revision #5

A Phase II Study of Tirapazamine (NSC-130181)/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer
Study Coordinator(s)Quynh-Thu X. Le, M.D., Stephen K. Williamson, M.D., Primo N. Lara, Jr., M.D., Zelanna Goldberg, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists
S0304Phase II

Amendment #1

A Phase II Feasibility Translational Research Trial of Induction Chemotherapy Followed by Concomitant Chemoradiation in Patients with Clinical T3-T4 Rectal Cancer
Study Coordinator(s)Charles R. Thomas Jr., M.D., Heinz- Josef Lenz, M.D., Robert P. Whitehead, M.D., James L. Abbruzzese, M.D., Stephen R. Smalley, M.D., Morton S. Kahlenberg, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists
S0310Phase II

Amendment #3

Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC).
Study Coordinator(s)Angela M. Davies, M.D., Raja Mudad, M.D., FACP, Peter F. Roberts, M.D., Derick H.M. Lau, M.D.,Ph.D., Deborah S. Ward, NP
ParticipantsLimited: Institutions Listed on the Title Page
S0325Phase IIb

Revision #1

A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (BMS-354825) (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase.
Action CodesER
Study Coordinator(s)Brian J. Druker, M.D., Marilyn L. Slovak, Ph.D., Jerald P. Radich, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, ECOG, CALGB, NCIC-CTG
S0336Phase II

Memorandum

Phase II Trial of Depsipeptide (NSC-630176) in Colorectal Cancer Patients Who Have Received Either One or Two Chemotherapy Regimens for Metastatic or Locally Advanced, Unresectable Disease
Study Coordinator(s)Robert P. Whitehead, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0341Phase II

Amendment #1

Phase II Trial of OSI-774 (NSC-718781) in Patients with Advanced Non-Small Cell Lung Cancer and a Performance Status of 2
Study Coordinator(s)Paul J. Hesketh, M.D., Antoinette J. Wozniak, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0356Phase II

Amendment #1

Oxaliplatin Plus Protracted Infusion 5-Fluorouracil and Radiation for Potentially Curable Esophageal Cancer: A Phase II Trial with Molecular Correlates
Action CodesAC, RC, FBR
Study Coordinator(s)Lawrence P. Leichman, M.D., Charles R. Thomas Jr., M.D., Kevin G. Billingsley, M.D., Thomas J. Watson, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons

Revision #28

Cytogenetic Studies in Leukemia Patients
Action CodesER
Study Coordinator(s)Diane Roulston, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU, Affiliates

Other New Items

  • IP - Pts Must Be Informed
  • AC - Consent Must Be Amended
  • CBR - No Registration Allowed until IRB Review
  • RC - Formal Re-consent Required
  • FBR - Full Board Review Required
  • ER - Expedited Review Acceptable
  • NR - No IRB Review Required