Trial & Business Updates:

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Priority Lists

Activations

Closures

30904Phase III Intergroup

Permanent Closure

A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma
Study Coordinator(s)Eila C. Skinner, M.D.
ParticipantsUCOP, Medical Oncologists, Surgeons, Pathologists, NCORP, Members
Closure Date2003-01-13
S0022Phase II

Permanent Closure

Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer
Study Coordinator(s)Raja Mudad, M.D., FACP, Laurie E. Gaspar, M.D., R. Chapman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists
Closure Date2003-02-01
S0101Phase II

Permanent Closure

A Phase II Study of Gemcitabine Plus Irinotecan (CPT-11) In Patients With Esophageal Cancer.
Study Coordinator(s)Stephen K. Williamson, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
Closure Date2003-02-01
S0127Phase II

Partial Temporary Closure and Revision #2

A Phase II Study of OSI-774 (NSC #718781) in Unresectable or Metastatic Adenocarcinoma of the Stomach and Gastroesophageal Junction
Study Coordinator(s)Tomislav Dragovich, M.D., Ph.D, James L. Abbruzzese, M.D.
ParticipantsMembers, NCORP
Closure Date2003-08-15

Amendments, Revisions, Memoranda

E4494Phase III Intergroup
Phase III Trial of CHOP versus CHOP and Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8) in Older Patients with Diffuse Mixed, Diffuse Large Cell and Immunoblastic Large Cell Histology Non-Hodgkin's Lymphoma
Study Coordinator(s)James K. Weick, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP
G0175Phase III Intergroup

Revision #5

A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days X 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days X 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma.
Study Coordinator(s)Carolyn M. Johnston, M.D.
ParticipantsMembers, NCORP
JBR10Phase III Intergroup

Memorandum

A Phase III Prospective Randomized Study of Adjuvant Chemotherapy with Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer with Companion Tumour Marker Evaluation
Study Coordinator(s)Robert B. Livingston, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, Surgeons, NCORP
JMA17Phase III Intergroup

Memorandum

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.
S0008Phase III Intergroup

Amendment #1

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
S0012Phase III

Revision

A Comparative Randomized Study of Standard Doxorubicin And Cyclophosphamide Followed by Weekly Paclitaxel Vs. Weekly Doxorubicin And Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel As Neoadjuvant Therapy For Inflammatory And Locally Advanced Breast Cancer
Study Coordinator(s)Georgiana K. Ellis, M.D., Robert B. Livingston, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, EPP, CTSU
S0124Phase III

Revision #2

Randomized Phase III Trial of Cisplatin and Irinotecan versus Cisplatin and Etoposide in Patients with Extensive Stage Small Cell Lung Cancer
Study Coordinator(s)Ronald B. Natale, M.D., David R. Gandara, M.D., Primo N. Lara, Jr., M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S0204Phase II

Revision #4

A Phase II Trial of Thalidomide/Dexamethasone Induction Followed by Tandem Melphalan Transplant and Prednisone/Thalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients, (A BMT Study)
Study Coordinator(s)Mohamad A. Hussein, M.D., John D. Shaughnessy, Jr., Ph.D., James A. Waldron, M.D.,Ph.D., Jeffrey A. Zonder, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Limited Institutions: BMT Members
S0211Phase II

Memorandum

A Phase II Trial of STI571 for the Treatment of Platinum and Taxane Refractory Stage III and IV Epithelial Ovarian Cancer and Primary Peritoneal Cancer
Study Coordinator(s)Andy Jang, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists
S9900Phase III Intergroup

Revision #12

A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB(T2N0), II (T1-2N1, T3N0) and Selected IIIA (T3N1) Non-Small Cell Lung Cancer (NSCLC).
Study Coordinator(s)Paul A. Bunn Jr., M.D., Katherine M. W. Pisters, M.D., Wilbur A. Franklin, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Surgeons, CTSU, ECOG, NCCTG, RTOG, ACOSOG, NCIC-CTG
S9927Phase III Intergroup

Revision

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-9430Phase II

Revision #10

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
  • 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