NCT02945033Active, not recruitingPhase 3
Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk
French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
Four retrospective studies were recently published on efficacy of aspirin in patients with surgically resected colon cancer. Two of these studies strongly suggested that aspirin used in low doses (100 mg/d) after surgical resection of colorectal cancer with PI3K mutation could act as a targeted therapy with a major protective effect on the risk of recurrence. The other two studies did not confirm the benefit of aspirin in this situation. These four retrospective studies provide an insufficient level of evidence to demonstrate the benefit of low-dose aspirin as adjuvant to surgery for colorectal cancer. Therefore, it is necessary as recommended in the conclusion of these studies and meta-analyses to perform a randomised prospective study to validate these data.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 264 (estimated)
- First submitted
- 20 Oct 2016
- Start date
- 12 Jul 2018
- Primary completion date
- Jul 2028
- Lead sponsor
- University Hospital, Rouen
- Diseases
- Colorectal cancer
- NCT number
- NCT02945033
- EU CT number
- 2024-516007-16-00
- EudraCT number
- 2016-002209-20
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 264
- From 12 Jul 2018 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Contraindication to Aspirin : Allergy to aspirin, Active or antecedent peptic ulcer
- Severe renal or hepatic insufficiency
- Rectal cancer
- Hereditary forms (i.e. lynch syndrome patients)
Other
- Anticoagulant and/or Antiaggregating treatment including clopidogrel
- Regular aspirin use (\> 3 doses per week during more than 3 months the last year)
- Pregnancy or nursing ongoing
- Follow-up of the patient not feasible
Who the study is looking for
- Age ≥ 18 years
- Colonic adenocarcinoma stage III
- Colonic adenocarcinoma stage II high risk MSS:
- T4bN0 or T4aN0 tumour penetrating the surface of the visceral peritoneum
- or less than 12 nodes evaluated;
- or with at least two of the following criteria:lymphatic involvement, perineural invasion, venous invasion
- or diagnosis of bowel obstruction or perforation; or poor differentiated tumour.
- PI3K mutation, exon 9 or 20 (tumour)
- Resection R0
- WHO performance status 0-2
- Chest and abdominal CT scan ≤ 8 weeks
- Life expectancy ≥ 3 years
- Written consent signed
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.