Trial & Business Updates:

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Priority Lists

Activations

CTSU/R9804Phase III

Activation

Phase III Trial of Tamoxifen Alone vs. Tamoxifen plus RT for Good Risk Duct Carcinoma in Situ (DCIS) of the Female Breast
Study Coordinator(s)Lori J. Pierce, M.D.
ParticipantsCTSU
S0023Phase III Intergroup

Activation

A Phase III Trial of Cisplatin/Etoposide/Radiotherapy with Consolidation Docetacel followed by Maintenance Therapy with ZD1839 (NSC-715055) or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
Study Coordinator(s)Karen Kelly, M.D., Laurie E. Gaspar, M.D., Wilbur A. Franklin, M.D., David R. Gandara, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, NCCTG, NCIC-CTG, CTSU, EPP
S0111Phase II

Activation

A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) (IND 59699) Administered Every 21 Days in Patients with Hormone Refractory Prostate Cancer
Study Coordinator(s)Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D., Wael A. Sakr, M.D., Michael A. Tainsky, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists

Closures

S9809Phase III

Permanent Closure: 7/1/01

The Effect of Fluoroquinolones on the Disease-Free Interval in Patients with Stage Ta Transitional Cell Carcinoma of the Bladder, Phase III
Study Coordinator(s)David P. Wood Jr., M.D., H. Barton Grossman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsUCOP, Medical Oncologists, Surgeons, NCORP, Members
Closure Date2001-07-01

Amendments, Revisions, Memoranda

JPR3Phase III Intergroup

Memorandum

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
N9831Phase III Intergroup

Memorandum

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
S0008Phase III Intergroup

Revision #8

Phase III Trial of High Dose Interferon Alpha-2b versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients with High Risk Melanoma
Study Coordinator(s)Lawrence E. Flaherty, M.D., John A. Thompson, M.D., Ralph J. Tuthill, M.D., John Vetto, M.D., Vernon K. Sondak, M.D., Jeffrey A. Sosman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, ECOG, COG, US INSTITUTIONS ONLY
S0033Phase III Intergroup

Amendment #1

"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
S9628Phase II Intergroup

Revision #6

Phase II Study of Dexamethasone/Alpha Interferon In AL Amyloidosis
Study Coordinator(s)Madhav V. Dhodapkar, M.D., Alan Solomon, M.D.
ParticipantsPathologists, CALGB, NCORP, Members
S9630Phase III Intergroup

Amendment #2

A Randomized Comparison of Medroxyprogesterone Acetate (MPA) and Observation For Prevention of Endometrial Pathology in Postmenopausal Breast Cancer Patients Treated with Tamoxifen
Study Coordinator(s)Ronald K. Potkul, M.D., Caryl G. Salomon, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, CALGB, NCORP
S9704Phase III Intergroup

Revision #10

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
S9917Phase III

Revision #3

L-Selenium-Based Chemoprevention of Prostate Cancer Among Men with High Grade Prostatic Intraepithelial Neoplasia
Study Coordinator(s)James R. Marshall, Ph.D., David P. Wood Jr., M.D., Wael A. Sakr, M.D., E. David Crawford, M.D., Ian M. Thompson Jr., M.D., Donna L. Berry, R.N.,Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, VA Special Member Institutions
S9922Phase III

Revision #5

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
S9925Ancillary

Amendment #2

Lung Cancer Specimen Repository Protocol, Ancillary
Study Coordinator(s)Wilbur A. Franklin, M.D., Paul H. Gumerlock, Ph.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, CTSU, NCIC-CTG, ECOG
S9927Phase III Intergroup

Revision #4

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-8855Ancillary Intergroup

Revision #4

Prognostic Value of Cytometry Measurements of Cellular DNA Parameters in Head and Neck Cancer Patients, Ancillary
Study Coordinator(s)John F. Ensley, M.D.
ParticipantsMembers, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, ECOG, RTOG, NCORP
SWOG-9430Phase II

Revision #8

A Phase II Trial of Complete Surgical Resection for Stage IV Melanoma-Surgical Resection with Biological and Clinical Follow-Up
Study Coordinator(s)Jeffrey A. Sosman, M.D., Vernon K. Sondak, M.D., James A. Warneke, M.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph J. Tuthill, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Surgeons, ECOG

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