Clinical trial NCT02945033: Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk
Official title: French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: Pi3k mutation
Aspirin
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Federation Francophone de Cancerologie Digestive
First posted: 2016-10-26
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
timeFrame: 3 years
Secondary outcomes:
measure: Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
timeFrame: 5 years
measure: Number of alive patient
timeFrame: 5 years
measure: Number of pills taken by the patient for compliance evaluation
timeFrame: every 6 months during 3 years
measure: Number of severe bleeding grade 3-4 events
timeFrame: 3 years
measure: Number of participants with treatment-related adverse events
timeFrame: 3 years
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Pierre MICHEL, Pr
role: PRINCIPAL_INVESTIGATOR
References: