Adjuvant Aspirin Treatment for Colon Cancer Patients
Summary
Following complete resection of their primary tumor, potentially eligible stage II or stage III colon cancer patients will undergo central PIK3CA testing. Patients with somatic mutations will be 2:1 randomized to daily aspirin 100 mg versus placebo for a a maximum of 3 years or until disease recurrence, patient death or withdrawal of consent, whichever occurs first. Patients will be followed up for at least 3 years from the date of surgery. The intake of aspirin or placebo is independent of adjuvant chemotherapy, and does not impact on the indication to give (or not to give) adjuvant chemotherapy.
Timeline
- Start
- 2016-06-09
- Primary completion
- 2023-09-14
- Completion
- 2023-09-14
Outcome
Missed primary endpoint
Stopped (Business): “Board decision in 2020 due to lack of financial funding.”
registry analysis (superiority test); Aspirin 100 mg vs Placebo; p = 0.11; Log Rank NCT02467582 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 100 mg | Oral |