Phase 3Active, not recruiting
S0820, Adenoma and Second Primary Prevention Trial (PACES)
A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES)
- Sponsor
- SWOG Cancer Research Network (Research network)
- Enrollment
- 354 enrolled
- Conditions
- Colorectal Neoplasms
- Interventions
- Eflornithine placebo & sulindac placebo; eflornithine & sulindac placebo; Eflornithine placebo & sulindac; Eflornithine plus sulindac
- Ages
- adults, older adults
- Registry
- NCT01349881
Full record on ClinicalTrials.gov
From the registry
The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon or rectal cancer.
Primary outcomes
- Event rate, defined as rate of high-risk adenoma or second primary colorectal cancer (CRC)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered