Actively Recruiting
Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk
Led by University Hospital, Rouen · Updated on 2026-02-18
264
Participants Needed
1
Research Sites
520 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Rouen
Lead Sponsor
F
Federation Francophone de Cancerologie Digestive
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
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
You will not qualify if you...
- Anticoagulant and/or Antiaggregating treatment including clopidogrel
- Regular aspirin use (> 3 doses per week during more than 3 months the last year)
- Contraindication to Aspirin : Allergy to aspirin, Active or antecedent peptic ulcer
- Severe renal or hepatic insufficiency
- Pregnancy or nursing ongoing
- Rectal cancer
- Hereditary forms (i.e. lynch syndrome patients)
- Follow-up of the patient not feasible
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Trial Site Locations
Total: 1 location
1
Rouen University Hospital
Rouen, France
Actively Recruiting
Research Team
P
Pierre MICHEL, Pr
CONTACT
J
Julien BLOT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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