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Phase III Randomized Study of Adjuvant Anticoagulation Therapy with Warfarin for Stage II/III Adenocarcinoma of the Colon
Basic Trial Information
Objectives I. Compare the effects of adjuvant warfarin anticoagulation therapy vs. no further treatment on the incidence of postoperative recurrence and on the duration of survival in patients with adenocarcinoma of the colon at high risk for developing future metastases (Stages II and III). II. Compare the effects of warfarin therapy vs. no further therapy on the number of metastases developing in these patients. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with Stage II/III adenocarcinoma of the colon. The preoperative chest x-ray, liver function parameters, and clotting studies must be normal. Patients with multiple polypoid lesions that are all or mostly removed at colonoscopy and those with polypoid lesions less than 2 cm on BAE are ineligible, as are those with positive margins at pathologic staging. The Karnofsky performance status must be 90-100 percent, and there may be no other serious disease that would preclude the likelihood of a 7-year survival. There may be no history of active ulcer disease, bleeding abnormalities, or medical condition that would make hemorrhage a potentially lethal event; patients may not be taking anticoagulants for other conditions. There may have been no other cancer, other than skin cancer, within 5 years of entry, and there may have been no prior radiation therapy of low sigmoid lesions. Expected Enrollment About 80 patients will be entered on each arm. Protocol closed July 1984. Outline Randomized study. Patients whose postoperative pathological staging is Stage II or III are randomized; those with a postoperative staging of I or IV are followed for 5 years, with further treatment at the discretion of the investigator. Arm I: Anticoagulation Therapy. Warfarin, NSC-59813. Arm II: No Further Treatment. Trial Lead Organizations Southeastern Cancer Study Group
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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