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Closures

N9831Phase III Intergroup

Partial Closure (Arm C) and Revision #5

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
Closure Date2005-04-30
S0101Phase II

Temporary Closure

A Phase II Study of Gemcitabine Plus Irinotecan (CPT-11) In Patients With Esophageal Cancer.
Study Coordinator(s)Stephen K. Williamson, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
Closure Date2003-02-01

Amendments, Revisions, Memoranda

C9732Phase III Intergroup

Revision #5

A Randomized Phase III Study Comparing Etoposide and Cisplatin with Etoposide, Cisplatin and Paclitaxel in Patients with Extensive Small Cell Lung Cancer
Study Coordinator(s)Karen Kelly, M.D.
ParticipantsMembers, Medical Oncologists, NCORP
E3695Phase III Intergroup

Revision #7

A Randomized Phase III Trial of Concurrent Biochemotherapy with Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon a-2b versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients with Metastatic Malignant Melanoma
Study Coordinator(s)Lawrence E. Flaherty, M.D.
ParticipantsMedical Oncologists, NCORP, Members
JPR3Phase III Intergroup

Revision #3

Intergroup (NCIC CTG, CUOG, ECOG, CALGB, SWOG) Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3 - 4, N0, M0 Adenocarcinoma of the Prostate
Action CodesER
Study Coordinator(s)Gregory P. Swanson, M.D.
ParticipantsUCOP, Medical Oncologists, Surgeons, Pathologists, NCORP, Members
N9741Phase III Intergroup

Memo

A Randomized Phase III Trial of Combinations of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU) and Irinotecan (CPT-11) as Initial Treatment of Patients With Advanced Adenocarcinoma of the Colon and Rectum
Study Coordinator(s)Stephen K. Williamson, M.D.
ParticipantsMembers, Surgeons, NCORP
N9841Phase III Intergroup

memo

A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients with Advanced Colorectal Carcinoma Previously Treated with 5-FU
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D.
ParticipantsMembers, Surgeons, NCORP
S0016Phase III

Revision #2

A Phase III Trial of CHOP vs. CHOP + Rituximab vs. CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) For Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
Study Coordinator(s)Oliver W. Press, M.D.,Ph.D., David G. Maloney, M.D.,Ph.D., Rita M. Braziel, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists, CALGB, CTSU
S0020Phase II

Revision #4

A PHASE II STUDY OF ANTI-THYMOCYTE GLOBULIN AND CYCLOSPORINE FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)
Study Coordinator(s)Charles Schiffer, M.D., Jeanne E. Anderson, M.D., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0033Phase III Intergroup

Revision #5

"Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)"
Study Coordinator(s)George Demetri, M.D., Christopher Fletcher, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, NCIC-CTG
S9704Phase III Intergroup

Revision #12

A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+ B Cell Lymphomas(with Possible Late Autologous Stem Cell Transplant) for Patients with Diffuse Aggressive Non-Hodgkin’s Lymphoma in the High-Intermediate and High Risk International Classification Prognostic Groups (A BMT Study)
Study Coordinator(s)Patrick J. Stiff, M.D., Avayporn P. Nademanee, M.D., Richard I. Fisher, M.D., Louis S. Constine, M.D., Raymond R. Tubbs, D.O., James Cook, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists, CALGB, ECOG, NCIC-CTG
S9921Phase III Intergroup

Revision #9

Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High Risk Prostate Cancer Patients Following Radical Prostatectomy, Phase III.
Study Coordinator(s)L. Michael Glode, M.D., Maha H.A. Hussain, M.D., Gregory P. Swanson, M.D., David P. Wood Jr., M.D., Wael A. Sakr, M.D.
ParticipantsMembers, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons, Radiation Oncologists, Pathologists, EPP, CALGB, CTSU Institutions in the United States
S9922Phase III

Amendment #3

A Phase III Trial of Dexamethasone, Cyclophosphamide, Etoposide, Cisplatin (DCEP) and G-CSF With or Without Thalidomide (NSC #66847) as Salvage Therapy for Patients with Refractory Multiple Myeloma
Study Coordinator(s)Mohamad A. Hussein, M.D., James K. Weick, M.D.
ParticipantsNCORP, Members
SWOG-8819Ancillary

Revision #13

Central Lymphoma Repository Tissue Procurement Protocol
Study Coordinator(s)Thomas P. Miller, M.D., Richard I. Fisher, M.D., Thomas M. Grogan, M.D.
ParticipantsMembers, NCORP
SWOG-8947Ancillary

Revision #13

Central Lymphoma Serum Repository Protocol
Study Coordinator(s)Richard I. Fisher, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP
SWOG-9321Phase III Intergroup

Memorandum

Standard Dose Versus Myeloablative Therapy For Previously Untreated Symptomatic Multiple Myeloma
Study Coordinator(s)Bart Barlogie, M.D.,Ph.D.
ParticipantsLimited Institutions: SWOG Approved Autologous BMT Facilities, CALGB, ECOG, NCORP, Members

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