Trial & Business Updates:

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Priority Lists

Activations

C80002Phase II

Activation

A Phase II Study of Local Excision Alone or Local Excision Plus Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers
Study Coordinator(s)Morton S. Kahlenberg, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons

Activation

Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)
Study Coordinator(s)Cynthia Jumper, M.D.
ParticipantsCTSU

Activation

Phase III Intergroup Trial of Adjuvant Chemoradiation after Resection of Gastric or Gastroesophageal Adenocarcinoma
Study Coordinator(s)Tomislav Dragovich, M.D., Ph.D
ParticipantsCTSU

Activation

A Phase III Study of Regional Radiation Therapy in Early Breast Cancer
Study Coordinator(s)Lori J. Pierce, M.D.
ParticipantsCTSU
S0127Phase II

Partial Reactivation

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

Closures

S0112Phase II

Permanent Closure

S0112, A Phase II Study Of Daunomycin And Ara-C, Both Given By Continuous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older.
Study Coordinator(s)Thomas R. Chauncey, M.D.,Ph.D., Alan F. List, M.D., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
Closure Date2003-04-01
S0218Phase II

Permanent Closure

A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) In Patients with Malignant Pleural Mesothelioma
Study Coordinator(s)Linda L. Garland, M.D., Michael Lobell, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
Closure Date2003-04-01

Amendments, Revisions, Memoranda

G0137Phase III Intergroup

Memorandum

A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma
ParticipantsMembers, NCORP, Surgeons, Pathologists
S0011Phase II

Revision #1

Phase II Trial of Surgery with Perioperative INGN 201 (Ad5CMV-p53) Gene Therapy Followed by Chemoradiotherapy for Advanced, Resectable Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx and Larynx
Study Coordinator(s)George Yoo, M.D., S.G. Urba, M.D., Harold Kim, M.D., Ehab Hanna, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0033Phase III Intergroup

Memorandum

"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
S0107Phase II

Memorandum

A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) Every 21 Days in Patients With Advanced Pancreas Cancer
Study Coordinator(s)Robert P. Whitehead, M.D.
ParticipantsMembers, NCORP
S0116Phase II

Revision #4

A Phase II Trial of a D1/3-MAGE-3-His Fusion Protein (NSC-719274) with Adjuvant SB-AS02B (NSC-719275) for Patients with Selected Stage IV, M1a or M1b Metastatic Melanoma
Study Coordinator(s)Jeffrey S. Weber, M.D., Vernon K. Sondak, M.D., Mary L. Disis, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0124Phase III

Amendment #1

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
S0218Phase II

Memorandum

A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) In Patients with Malignant Pleural Mesothelioma
Study Coordinator(s)Linda L. Garland, M.D., Michael Lobell, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S9925Ancillary

Memorandum

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
S9925Ancillary

Revision #4 (Revised)

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
SWOG-9444Ancillary

Amendment #1

Gastrointestinal Tumor Repository Protocol, Ancillary
Study Coordinator(s)Cecilia M. Fenoglio-Preiser, M.D., Grant N. Stemmermann, M.D., Amy E. Noffsinger, M.D., Paul E. Hurtubise, M.D.
ParticipantsMembers, Pathologists, NCORP
SWOG-9444Ancillary

Revision #5

Gastrointestinal Tumor Repository Protocol, Ancillary
Study Coordinator(s)Cecilia M. Fenoglio-Preiser, M.D., Grant N. Stemmermann, M.D., Amy E. Noffsinger, M.D., Paul E. Hurtubise, M.D.
ParticipantsMembers, Pathologists, NCORP

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