Current Clinical Trials at UIHC: GI Oncology Protocols: Prevention of Metachronous Colorectal Ca.
James R. Howe, M.D.
Peer Review Status: Internally Peer
Reviewed
Objective:
This trial proposes to look at only patients who have previously had colon cancer, because these patients have already demonstrated a colonic mucosa at risk for carcinoma. The incidence of metachronous colorectal cancer is 1-7% (depending on surveillance).
It has been shown that non-steroidal anti-inflammatory agents have a protective effect against colorectal cancer. In a study of 662,424 adults, those who took aspirin at least 16 times per month had a 40% lower incidence of colorectal cancer (NEJM 325:1593, 1991). Pts. with FAP have been found to have regression of rectal polyps when treated with Sulindac as compared to placebo (Gastroenterol. 101:635, 1991).
One of the hypothesized mechanisms of action is inhibition of prostaglandins, which may promote tumor development or are possibly immunosuppressive. However, it is not truly known what the mechanism is at this time.
Aspirin has been chosen because it has little toxicity and low cost.
Pts. who have recently undergone resection of Dukes A or B1 tumors or those 5 yrs. out from resection of B2 and C tumors and adjuvant therapy have an initial screening colonoscopy, then receive 325 mg ASA or placebo per day for 3 years. They will then have follow-up colonoscopy where the presence of adenomas or carcinomas will be assessed in both groups.
The projected accrual for this study is 890, and 252 patients have been entered over 33 months.
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