NCT02945033 Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk
| NCT ID | NCT02945033 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Rouen |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2018-07-12 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 264 participants in total. It began in 2018-07-12 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Pierre MICHEL, Pr
PRINCIPAL INVESTIGATOR
University Hospital, Rouen
Frequently Asked Questions
Who can join the NCT02945033 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02945033 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 264 participants.
Is NCT02945033 currently recruiting?
Yes, NCT02945033 is actively recruiting participants. Contact the research team at pierre.michel@chu-rouen.fr for enrollment information.
Where is the NCT02945033 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT02945033 clinical trial?
NCT02945033 is sponsored by University Hospital, Rouen. The principal investigator is Pierre MICHEL, Pr at University Hospital, Rouen. The trial plans to enroll 264 participants.
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