Clinical Research Protocols

Clinical Research Protocols in Colorectal Cancer

Compiled by Margaret Gross-King, RN, MS, OCN
Clinical Research Manager, H. Lee Moffitt Cancer Center & Research Institute

(Editor's note: This compilation of clinical studies of carcinoma of the colon and rectum focuses on research being performed in the United States by the major cooperative study groups, although protocols from individual institutions that address manageme nt of hepatic metastases also have been included. Readers who would like a complete listing including foreign studies should access PDQ at 1-800-4-CANCER.)

NCI High-Priority Studies

NCCTG-914652 INT-0130 Phase III Randomized Trial of Adjuvant 5-FU/LEV With vs Without Radiotherapy in Patients With Completely Resected Adenocarcinoma of the Colon at High Risk of Locoregional Recurrence (Summary last modified 12/95).
Chairman: Michael J. O'Connell, Mayo Clinic, Rochester, Minn. Lead Organization: North Central Cancer Treatment Group. Acceptable age range: 18 and over.

NCCTG-934653 INT-0146 Phase III Randomized Study of Laparoscopic-Assisted Colectomy vs Open Colectomy for Colon Cancer (Summary last modified 11/95).
Chairman: Heidi Nelson, Mayo Clinic, Rochester, Minn. Lead Organization: North Central Cancer Treatment Group. Acceptable age range: 18 and over.

Screening/Prevention Trials

PLCO-1 NCI-P93-0050 A 16-Year Randomized Screening Trial for Prostate, Lung, Colorectal and Ovarian Cancer (Summary last modified 5/95).
Chairman: John K. Gohagan, National Cancer Institute, National Institutes of Health, Bethesda, Md. Lead Organization: Early Detection Branch, National Cancer Institute. Acceptable age range: 60 to 74.

CLB-9270 NCI-P93-0048 Phase III Randomized Chemoprevention Study of Aspirin in Patients With Curatively Treated Dukes Stage A/B1/B2/C Colorectal Cancer (Summary last modified 10/95).
Chairman: Robert S. Sandler, University of North Carolina School of Medicine, Chapel Hill, NC. Lead Organization: Cancer and Leukemia Group B. Acceptable age range: over 30 to under 75.

DMS-ASPIRIN NCI-P95-0063 Randomized, Double-Blind, Placebo-Controlled Study of Two Different Doses of Aspirin and Folic Acid (1 mg/day) for the Prevention of Recurrent Neoplastic Polyps of the Large Bowel in Patients With a History of Large Bowel A denoma (Summary last modified 7/95).
Chairman: John Baron, Norriss Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH. Lead Organization: Norriss Cotton Cancer Center. Acceptable age range: 21 to 80.

E-8292 NCI-P95-0066 Phase III Randomized, Double-Blind, Placebo-Controlled Study of High-Dose Folic Acid for the Prevention of Colorectal Cancer in Patients With Resected Adenomatous Polyps (Summary last modified 7/95).
Chairman: Joel Mason, New England Medical Center, Boston, Mass. Lead Organization: Eastern Cooperative Oncology Group. Acceptable age range: 30 and over.

SWOG-9041 NCI-P92-0031 Pilot, Randomized, Placebo-Controlled Study of Calcium for Chemoprevention of Colorectal Adenomas and New Primary Carcinomas in Surgically Treated Patients (Summary last modified 2/95).
Chairman: David A. J. Chu, Beckman Research Institute of the City of Hope, Duarte, Calif. Lead Organization: Southwest Oncology Group. Acceptable age range: any age.

UCI-DFMO/COLON NCI-P92-0007 Phase IIb Cancer Prevention Trial of the Effect of the Polyamine Synthesis Inhibitor DFMO on Colon Mucosa (Summary last modified 9/95).
Chairman: Frank L. Meyskens, Jr., University of California Irvine Clinical Cancer Center, Orange, Calif. Lead Organization: University of California Irvine Clinical Cancer Center. Acceptable age range: 40 to 80.

Adjuvant and Neoadjuvant Trials

E-1292, INT-0136 Phase III, Randomized, Intergroup Study of Perioperative 5-FU vs No Perioperative 5-FU Following Curative Resection of Dukes Stage B2/B3/C Colon Cancer, With Adjuvant 5-FU/LEV for B3/C Patients (Summary last modified 10/93).
Chairman: Mary Margaret Kemeny, North Shore University Hospital, Manhasset, NY. Lead Organization: Eastern Cooperative Oncology Group. Acceptable age range: 18 and over.

NCCTG-914653 INT-0135 Phase III Randomized Study of Adjuvant Chemotherapy With High-Dose vs Standard-Dose LEV Combined With 5-FU/CF in Patients With Completely Resected, High-Risk Adenocarcinoma of the Colon (Summary last modified 11/95).
Chairman: Michael J. O'Connell, Mayo Clinic, Rochester, Minn. Lead Organization: North Central Cancer Treatment Group. Acceptable age range: any age.

SWOG-9415 INT-0153 Phase III Randomized Study of Bolus 5-FU/CF/LEV vs Continuous-Infusion 5-FU/LEV as Adjuvant Therapy for Completely Resected High-Risk Colon Cancer (Summary last modified 8/95).
Chairman: Elizabeth A. Poplin, Massey Cancer Center, Medical College of Virginia, Richmond, Va. Lead Organization: Southwest Oncology Group. Acceptable age range: any age.

NSABP-R-03 Phase III Randomized Study of Preoperative vs Postoperative 5-FU/CF/Radiotherapy in Patients With Operable Adenocarcinoma of the Rectum (Summary last modified 10/94).
Chairman:Norman Wolmark,Alle-gheny General Hospital, Pittsburgh, Penn. Lead Organization: National Surgical Adjuvant Breast and Bowel Project. Acceptable age range: 18 to 76.

RTOG-9401 INT-0147 Phase III Intergroup Randomized Study of Preoperative vs Postoperative Combined 5-FU/CF and Radiotherapy for Resectable Rectal Adenocarcinoma (Summary last modified 11/95).
Chairman: Bruce David Minsky, Memorial Sloan-Kettering Cancer Center, New York, NY. Lead Organization: Radiation Therapy Oncology Group. Acceptable age range: over 18.

SWOG-9304 INT-0144 Phase III Randomized Study of Adjuvant 5-FU in Patients With Stages B2/B3/C Rectal Cancer: Bolus vs Prolonged Venous Infusion (PVI) 5-FU Before and After Pelvic Irradiation, Each With PVI 5-FU Radiosensitization, vs Bolus Radiose nsitization (Summary last modified 8/95).
Chairman: Stephen R Smalley, Therapeutic Radiologists, Inc., Kansas City, Mo. Lead Organization: Southwest Oncology Group. Acceptable age range: over 18.

Advanced Disease Treatment Trials

NCCTG-894652 Phase III Randomized Trial of Intravenous L-Leucovorin vs Oral D,L-Leucovorin vs Intravenous D,L-Leucovorin Combined With Intensive-Course 5-FU in Patients With Advanced Colorectal Carcinoma (Summary last modified 8/95).
Chairman: Alan K. Hartfield, Carle Cancer Center, Urbana, Ill. Lead Organization: North Central Cancer Treatment Group. Acceptable age range: any age.

E-4293 Phase II Study of Topotecan as a 21-Day Infusion in Metastatic Colorectal Cancer (Summary last modified 10/94).
Chairman: Howard S. Hochster, Kaplan Comprehensive Cancer Center, New York, NY. Lead Organization: Eastern Cooperative Oncology Group. Acceptable age range: over 18.

NCCTG-924651 Phase I/II Pilot Study of 5-FU/CF and Pelvic Radiotherapy for Unresectable Large Bowel Cancer Confined to the Pelvis (Summary last modified 11/95).
Chairman: James A. Martenson, Jr., Mayo Clinic, Rochester, Minn. Lead Organization: North Central Cancer Treatment Group. Acceptable age range: 18 and over.

Hepatic Metastases

EST-9288 INT-0103 Phase III Comparison of Intrahepatic Artery FUdR and Systemic 5-FU vs No Chemotherapy Following Resection of 1-3 Hepatic Metastases in Patients With Colorectal Cancer (Summary last modified 7/92).
Chairman: Mary Margaret Kemeny, North Shore University Hospital, Manhassett, NY. Lead Organization: Eastern Cooperative Oncology Group. Acceptable age range: 18 and over.

MSKCC-91137A6 NCI-V92-0023 Phase III Randomized Study of Adjuvant Hepatic Arterial FUdR Plus Systemic 5-FU With or Without CF vs Systemic 5-FU With or Without CF Alone in Resected Hepatic Metastases From Colorectal Cancer (Summary last modified 12/ 95). Chairman: Nancy E. Kemeny, Memorial Sloan-Kettering Cancer Center, New York, NY. Lead Organization: Memorial Sloan-Kettering Cancer Center. Acceptable age range: 18 and over. NCCTG-924652 Phase II Study of Multiple Metastasectomy Combined With Systemic 5-FU/CF and Hepatic Artery Infusion of FUdR in Patients With Colorectal Carcinoma Metastatic to the Liver (Summary last modified 11/95).
Chairman: John S. Bolton, Oschner Cancer Institute, New Orleans, La. Lead Organization: North Central Cancer Treatment Group. Acceptable age range: 20 and over.

BRMP-8917 NCI-T89-0206N NCI-90-C-190 Phase I Study of FUdR Administered by a Modified Hepatic Artery Catheter Plus Oral CF Given in Combination With Systemic 5-FU/IFN-A in Patients With Colon Carcinoma Metastatic to the Liver (Summary last modified 6/95).
Chairman: John Edward Janik, Biological Response Modifiers Program, National Cancer Institute. Lead Organization: National Cancer Institute. Acceptable age range: 18 and over.

Legend for Abbreviations:

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