Trial & Business Updates:

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Priority Lists

Activations

S0033Phase III Intergroup
"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

Closures

Amendments, Revisions, Memoranda

JMA17Phase III Intergroup

Memorandum and Revision #3 (This study is not coordinated by the Southwest Oncology Group and we do not have access to an electronic version. Paper copies of this Revision and Memo are available and have been mailed to participating institutions.)

A Phase III Randomized Double Blind Study of Letrozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
Study Coordinator(s)Silvana Martino, D.O.
JPR7Phase III Intergroup

Amendment #2 (This study is not coordinated by the Southwest Oncology Group and we do not have access to an electronic version. Paper copies of this Amendment are available and have been mailed to participating institutions.)

Intergroup (NCIC, SWOG) Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients with Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer
Study Coordinator(s)Celestia S. Higano, M.D.
ParticipantsUCOP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, NCORP, Members
S9921Phase III Intergroup

Revision #5 and Memorandum

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
S9927Phase III Intergroup

Revision #1

Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes, Phase III
Study Coordinator(s)Lori J. Pierce, M.D.
ParticipantsMedical Oncologists, Radiation Oncologists, Surgeons, NCCTG, RTOG, ACOSOG, ECOG, CALGB, NCORP, Members, NCIC-CTG, NSABP
SWOG-9346Phase III Intergroup

Revision #15

Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer, Phase III
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
SWOG-9426Phase II

Revision #4

A Phase II Trial of Antiandrogen Withdrawal In Patients with Progressive Prostate Cancer
Study Coordinator(s)A. Oliver Sartor, M.D., Mario A. Eisenberger, M.D., E. David Crawford, M.D., Maha H.A. Hussain, M.D.
ParticipantsUCOP, Medical Oncologists, Surgeons, Pathologists, 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