Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High … (NCT02945033) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk
France264 participantsStarted 2018-07-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first