Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed no age specified SEG-GI-82351

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 Contact Information

Trial Lead Organizations

Southeastern Cancer Study Group

Walley Temple, MD, Protocol chair		Ph: 403-521-3914