SWOG S0820, Adenoma and Second Primary Colorectal Cancer Prevention Trial (PACES)
The study is designed to investigate whether eflornithine, sulindac or both are effective in preventing or delaying adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer.
The primary objective is to assess whether eflornithine and/or sulindac are effective in reducing the recurrence rate at 3 years.
The study will enroll approximately 1340 participants from hundreds of cancer centers in the US.
In addition to other conditions for enrollment, eligible patients have a history of stage 0-III colon cancer that was surgically removed up to 1 year previously; rectosigmoid cancers are eligible if no prior radiation therapy, no evidence of cancer by colonoscopy exam at time of study entry, and able to take oral medications.
Patients who have a history of uncontrolled hypertension or gastric/duodenal ulcer within past year or other medical conditions may not be eligible to enroll.