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Priority Lists

Activations

Closures

S0337Phase III

Permanent Closure - Effective 8/15/12

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
Action CodesER
Study Coordinator(s)Edward M. Messing, M.D., Deepak M. Sahasrabudhe, M.D., Theresa M. Koppie, M.D., David P. Wood Jr., M.D., Philip C. Mack, Ph.D.
ParticipantsMembers, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons, Pathologists
Closure Date2012-08-15

Amendments, Revisions, Memoranda

S0226Phase III

Memorandum - Fulvestrant Safety Report

Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer.
Action CodesER
Study Coordinator(s)Rita S. Mehta, M.D., Kathy Albain, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU
S0337Phase III

Revision #5

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
Action CodesER
Study Coordinator(s)Edward M. Messing, M.D., Deepak M. Sahasrabudhe, M.D., Theresa M. Koppie, M.D., David P. Wood Jr., M.D., Philip C. Mack, Ph.D.
ParticipantsMembers, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons, Pathologists
S0500Phase III

Memorandum - Veridex Cellsave Tubes

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
Action CodesNR
Study Coordinator(s)Jeffrey B. Smerage, M.D. Ph.D., Daniel F. Hayes, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU Institutions in the United States
S0600Phase III

Memorandum - Leucovorin Recall

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
Action CodesNR
Study Coordinator(s)Philip Gold, M.D., Anthony Shields, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S0805Phase II

Memorandum - Leucovorin Recall

Phase II Study of Combination of Hyper-CVAD and Dasatinib with or without Allogeneic Stem Cell transplant in Patients with Philadelphia (Ph) Chromosome Positive and/or Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL)
Action CodesNR
Study Coordinator(s)Farhad Ravandi, M.D., Susan O'Brien, M.D., Stephen J. Forman, M.D., Chul S. Ha, M.D., Jeffrey Y.C. Wong, M.D., Jerald P. Radich, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, BMT CTN
S0816Phase II Intergroup

Revision #12

A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma using Interim FDG-PET Imaging
Action CodesIP, AC, ER
Study Coordinator(s)Oliver W. Press, M.D.,Ph.D., Jonathan W. Friedberg, M.D., Richard K.J. Brown, M.D., Lisa M. Rimsza, M.D., James Cook, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CALGB, ECOG
S0910Phase II

Memorandum - Epratuzumab Safety Reports

A Phase II Study of Epratuzumab in Combination with Cytarabine and Clofarabine for Patients with Relapsed or Refractory Precursor B-cell Acute Lymphoblastic Leukemia
Action CodesER
Study Coordinator(s)Anjali S. Advani, M.D., Steven E. Coutre, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0927Phase III

Revision #1

Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain in Women with Early Stage Breast Cancer, Phase III
Action CodesAC, ER
Study Coordinator(s)Dawn Hershman, M.D., M.S., Katherine Crew, M.D., M.S., Carol M. Moinpour, Ph.D.
ParticipantsMembers, NCORP, Affiliates, Pathologists
S1201Phase II Pilot

Memorandum - Leucovorin Recall

A Randomized Phase II Pilot Study Prospectively Evaulating Treatment for Patients Based on ERCC1 (Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer
Action CodesNR
Study Coordinator(s)Syma Iqbal, M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
SWOG-9346Phase III Intergroup

Revision #23

Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer, Phase III
Action CodesER
Study Coordinator(s)Maha H.A. Hussain, M.D., Celestia S. Higano, M.D., Brian J. Miles, M.D., Paul H. Lange, M.D., E. David Crawford, M.D., Donna L. Berry, R.N.,Ph.D., Carol M. Moinpour, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, EORTC, EPP, NCIC-CTG

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