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Phase III Randomized Study of Surgery with or without Intraportal 5-FU/MITO Followed by 5-FU/LEV with or without CF in Stage II/III Colorectal Cancer
Alternate Title Surgery and Combination Chemotherapy in Treating Patients With Colorectal Cancer
Objectives I. Determine the efficacy of adjuvant portal chemotherapy with fluorouracil (5-FU) and mitomycin and systemic adjuvant chemotherapy with 5-FU/levamisole with or without leucovorin in patients with stage II/III colorectal cancer (Dukes stage B/C). Entry Criteria Disease Characteristics: Histologically confirmed colorectal carcinoma Stage II/III (Dukes' B/C) Eligible for curative resection (with at least 2-cm margins for rectal cancer) Prior/Concurrent Therapy: No prior chemotherapy Patient Characteristics: Age: Under 75 Performance status: Karnofsky 80%-100% Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hepatic: Bilirubin less than 2 mg/dL Renal: Creatinine less than 1.2 mg/dL Cardiovascular: No cardiopathy Other: No psychiatric disorder that would impede follow-up Expected Enrollment 800 patients will be accrued. Outline Randomized study. All patients are randomized before surgery to Arms I and II and after surgery to Arms III and IV. Patients with rectal or rectosigmoidal tumors receive radiotherapy on Regimen A. The following acronyms are used: CF Leucovorin calcium, NSC-3590 5-FU Fluorouracil, NSC-19893 LEV Levamisole, NSC-177023 MITO Mitomycin, NSC-26890 Arm I: Surgery followed by 2-Drug Combination Intraportal Chemotherapy. Radical resection; followed by 5-FU; MITO. Arm II: Surgery. Radical resection. Arm III: Single-Agent Systemic Chemotherapy with Drug Modulation. 5-FU; with LEV. Arm IV: Single-Agent Systemic Chemotherapy with Drug Modulation. 5-FU; with LEV; CF. Regimen A: Radiotherapy. Irradiation of tumor bed using linear accelerator or Co60 source.Published Results Bury J, Focan C, Beauduin ML, et al.: Portal and systemic chemotherapy for Dukes B2 and C colorectal cancer. An intermediary report on a double randomized trial. [Abstract] Proceedings of the American Society of Clinical Oncology 16 : A942, 1997. Focan C, Bury J, Beauduin M, et al.: Portal and systemic chemotherapy for Dukes B2 and C colorectal cancer: an intermediary report on a double randomized trial. [Abstract] VIth EORTC GITCCG Symposium 1996: an update after 25 years of experience 76, 1996. Related PublicationsLongrée L, Focan C, Bury J, et al.: Levamisole adds granulocyte toxicity to 5FU-based chemotherapies in adjuvant treatment of Dukes B-C colorectal cancer. A preliminary report. Anticancer Res 15 (4): 1561-4, 1995 Jul-Aug.[PUBMED Abstract] Trial Lead Organizations Clinique Saint-Joseph
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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