Trial & Business Updates:

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Priority Lists

Activations

S0016Phase III

Activation

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

Closures

Amendments, Revisions, Memoranda

C19801Phase II Intergroup

Amendment #1

A Phase II Study of 506U78 in Patients with Refractory or Relapsed T-Lineage Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)
Study Coordinator(s)Steven E. Coutre, M.D., Alison T. Stopeck, M.D.
ParticipantsPathologists, NCORP, Members
N9741Phase III Intergroup

Revision #5 regarding NCCTG Addendum #10

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

Revision #4 regarding NCCTG Addendum #5.

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
R9811Phase III Intergroup

Activation Notice

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
S0010Phase II

Amendment #1

A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-Cell Acute Lymphoblastic Leukemia (ALL)
Study Coordinator(s)Steven E. Coutre, M.D., David R. Head, M.D., David H. Boldt, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S9701Phase III

Revision #10

Phase III Randomized Trial of 12 Months VS 3 Months of Paclitaxel in Patients with Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy (Intergroup)
Study Coordinator(s)Maurie Markman, M.D., Bradley J. Monk, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, Pathologists, Surgeons, GOG, NCORP
S9807Ancillary

Revision #2

Repository for Paraffin Embedded Tissues from Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).
Study Coordinator(s)Wolfram E. Samlowski, M.D., Heinz- Josef Lenz, M.D., Joseph A. Holden, M.D., Kurt H. Albertine, Ph.D.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP
S9920Phase III

Revision #2

A Phase III Randomized Study Comparing Busulfan – Total Body Irradiation Versus Cyclophosphamide – Total Body Irradiation Preparative Regimen in Patients with Advanced Myelodysplastic Syndrome (MDS) or MDS – Related Acute Myeloid Leukemia (AML) Undergoing HLA-Identical Sibling Peripheral Blood Stem Cell Transplantation, (A BMT Study)
Study Coordinator(s)Jeanne E. Anderson, M.D., Karl G. Blume, M.D., Margaret R. O'Donnell, M.D., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsLimited Institutions: SWOG Approved Autologous BMT Facilities
S9922Phase III

Amendment #1

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
S9923Phase II

Memorandum concerning adverse events

A Phase II Trial of R115777 (NSC #70818) in Patients with Advanced Colorectal Cancer.
Study Coordinator(s)Robert P. Whitehead, M.D., John S. Macdonald, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S9924Phase II

Memorandum regarding adverse events

A Phase II Trial of R115777 (NSC #70818) in Patients with Advanced Pancreas Cancer.
Study Coordinator(s)John S. Macdonald, M.D., Robert P. Whitehead, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
SWOG-9342Ancillary

Amendment #3

A Study of the Late Cardiac Effects of Two Different Adjuvant Chemotherapy Regimens in Women With Node Negative Breast Cancer Treated on SWOG-8897
Study Coordinator(s)Patricia A. Ganz, M.D., Laura F. Hutchins, M.D.
ParticipantsMembers, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, NCORP
  • 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