Colorectal Cancer
Conditions
Keywords
Pi3k mutation, Aspirin
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.
Interventions
DRUGaspirin intake
Patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years
DRUGplacebo intake
Patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years
PROCEDURESurgical resection of colonic adenocarcinoma stage III or II high risk
Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines
BIOLOGICALMolecular analysis of exon 9 and 20 of PI3K
Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece
BIOLOGICALblood intake
Blood intake will be done every 6 months to evaluate patient compliance to treatment
Sponsors
University Hospital, Rouen
Federation Francophone de Cancerologie Digestive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first | 5 years | — |
| Number of alive patient | 5 years | — |
| Number of pills taken by the patient for compliance evaluation | every 6 months during 3 years | Number of pills taken by the patient will be assess in order to evaluate patient's compliance |
| Number of severe bleeding grade 3-4 events | 3 years | — |
| Number of participants with treatment-related adverse events | 3 years | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPierre MICHEL, Pr
University Hospital, Rouen
Outcome results
None listed