Trial & Business Updates:

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Priority Lists

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Closures

S9623Phase III Intergroup

PERMANENT CLOSURE: Effective 2/15/01

A Comparison of Intensive Sequential Chemotherapy using Doxorubicin plus Paclitaxel plus Cyclophosphamide with High Dose Chemotherapy and Autologous Hematopoietic Progenitor Cell Support for Primary Breast Cancer in Women with >= 4 Involved Axillary Lymph Nodes, Phase III, Intergroup.
Study Coordinator(s)Scott I. Bearman, M.D., William P. Peters, M.D.,Ph.D., Lori J. Pierce, M.D.
ParticipantsMembers, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, ECOG, CALGB, NCCTG, NCORP
Closure Date2001-02-15
S9719Ancillary

PERMANENT CLOSURE: Effective 2/15/01

Clonal Hematopoiesis as a Marker of Genetic Damage Pilot Study Following Adjuvant Chemotherapy for Breast Cancer: Pilot Study to Evaluate Incidence, Ancillary to S9623
Study Coordinator(s)Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D., Wendy Stock, M.D.
ParticipantsMedical Oncologists, Pathologists, NCORP, Members
Closure Date2001-02-01
SWOG-9149Phase II

Permanent Close: Effective 2/15/01

A Phase II Study of Cisplatin Preceded by a 12-Hour Continuous Infusion of Concurrent Hydroxyurea and Cytosine Arabinoside (Ara-C) for Adult Patients with Malignant Gliomas
Study Coordinator(s)Lode J. Swinnen, M.D., Jeannette J. Townsend, M.D., Peter C. Burger, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP
Closure Date2001-02-15

Amendments, Revisions, Memoranda

N9831Phase III Intergroup

Revision #2

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
S0003Phase III

Revision #1

Randomized Phase III Trial of Carboplatin and Paclitaxel plus Tirapazamine versus Carboplatin and Paclitaxel in Patients with Advanced Non-Small Cell Lung Cancer Cisplatin, Paclitaxel, Tirapazamine vs. Cisplatin, Paclitaxel Specimen submission per S9925
Study Coordinator(s)Stephen K. Williamson, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, EPP, CTSU
S0033Phase III Intergroup

Revision #2

"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
S9701Phase III

Revision #9

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
S9709Phase II

Revision #6

A Phase II Study to Evaluate Transoral CO2 Laser Supraglottic Laryngectomy and Irradiation in Stage I, II and III Squamous Cell Carcinoma of the Supraglottic Larynx
Study Coordinator(s)R. Kim Davis, M.D., Amit Agrawal, M.D., Joseph Valentino, M.D., P.G. Shankar Giri, M.D., Wael A. Sakr, M.D.
S9912Phase II

Revision #2

Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women with Optimally-Debulked Stage III Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Study Coordinator(s)Harriet O. Smith, M.D., Amy D. Tiersten, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, Surgeons, Pathologists, NCORP
S9921Phase III Intergroup

Revision #6

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

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