Trial & Business Updates:

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Priority Lists

Activations

S1304Phase II Intergroup

Memorandum - Distribution for IRB Review Only

A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease
Study Coordinator(s)Sikander Ailawadhi, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S1313Phase I-II

Memorandum - Distribution for IRB Review Only

A Phase Ib/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) versus Modified FOLFIRINOX Alone in Patients with Good Performance Status Metastatic Pancreatic Adenocarcinoma
Study Coordinator(s)Ramesh K. Ramanathan, M.D., Philip A. Philip, M.D.,Ph.D.
ParticipantsLimited: Institutions Listed on the Title Page

Closures

CTSU/E1505Phase III Intergroup

Permanent Closure - Effective 9/20/13

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)
Study Coordinator(s)David R. Gandara, M.D., Eric Vallieres, M.D.
ParticipantsCTSU
Closure Date2013-09-20

Amendments, Revisions, Memoranda

S0713Phase II

Memorandum - Cetuximab Drug Order Form

A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-operative Therapy of Rectal Cancer
Action CodesNR
Study Coordinator(s)Cynthia G. Leichman, M.D., Stephen R. Smalley, M.D., Kevin G. Billingsley, M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Surgeons
S0819Phase III Intergroup

Memorandum - Cetuximab Drug Order Form

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)
Action CodesNR
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D., David R. Gandara, M.D., Thomas J. Semrad, M.D., Fred R. Hirsch, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, CTSU Institutions in the United States
S0820Phase III

Memorandum - Master Forms Set Update

A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)"
Action CodesNR
Study Coordinator(s)Jason A. Zell, D.O.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S0820Phase III

Revision #1

A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)"
Action CodesNR
Study Coordinator(s)Jason A. Zell, D.O.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S0919Phase II

Memorandum - Master Forms Set Update

A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)
Action CodesNR
Study Coordinator(s)Anjali S. Advani, M.D., Edward Copelan, MD, Cheryl L. Willman, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S1014Phase II

Memorandum - Abiraterone Acetate Safety Reports

Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.
Study Coordinator(s)Thomas W. Flaig, M.D., Maha H.A. Hussain, M.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons
S1200Phase III

Revision #4

Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women with Early Stage Breast Cancer
Action CodesER, NR
Study Coordinator(s)Dawn Hershman, M.D., M.S., Katherine Crew, M.D., M.S.
ParticipantsLimited: Institutions Listed on the Title Page

Memorandum - Master Forms Set Update

A Sero-Epidemiologic Survey and Cost-effectiveness Study of Screening for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Patients
Action CodesER, NR
Study Coordinator(s)Scott Ramsey, M.D.
ParticipantsSWOG, NCORP, Affiliates, Medical Oncologists

Revision #1

A Sero-Epidemiologic Survey and Cost-effectiveness Study of Screening for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Patients
Action CodesER, NR
Study Coordinator(s)Scott Ramsey, M.D.
ParticipantsSWOG, NCORP, Affiliates, Medical Oncologists
S1211Phase I-II

Memorandum 1 of 2 - Elotuzumab Safety Report

A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
Action CodesER, NR
Study Coordinator(s)Saad Usmani, M.D., Sikander Ailawadhi, M.D., Jatin Shah, MD
ParticipantsLimited: Institutions Listed on the Title Page , Members, NCORP, Affiliates, Medical Oncologists, Pathologists
S1211Phase I-II

Memorandum 2 of 2 - Master Forms Set Update

A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
Action CodesER, NR
Study Coordinator(s)Saad Usmani, M.D., Sikander Ailawadhi, M.D., Jatin Shah, MD
ParticipantsLimited: Institutions Listed on the Title Page , Members, NCORP, Affiliates, Medical Oncologists, Pathologists
S1312Phase I

Memorandum - Forms Updates

A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination with CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients with Relapsed/Refractory CD22-Positive Acute Lymphoblastic Leukemia (including B-ALL, Mixed Phenotypic Leukemia and Burkitt's Leukemia)
Action CodesNR
Study Coordinator(s)Anjali S. Advani, M.D., Michaela Liedtke, MD
ParticipantsLimited: Institutions Listed on the Title Page

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