Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk

NCT02945033 | Recruiting Phase 3

• 1 other identifier: 2015/222/HP
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Pi3k mutation; Aspirin

Outcome Measures

Primary Outcomes (1)

• Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first

  3 years

Secondary Outcomes (5)

• 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 severe bleeding grade 3-4 events

  3 years

• Number of participants with treatment-related adverse events

  3 years

Study Arms (2)

Patient with aspirin intake

EXPERIMENTAL

Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines. Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece. If the mutation is detected, patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years. Blood intake will be done every 6 months to evaluate patient compliance to treatment

Drug: aspirin intake; Procedure: Surgical resection of colonic adenocarcinoma stage III or II high risk; Biological: Molecular analysis of exon 9 and 20 of PI3K; Biological: blood intake

Patient with placebo intake

PLACEBO COMPARATOR

Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines. Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece. If the mutation is detected, patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years. Blood intake will be done every 6 months to evaluate patient compliance to treatment

Drug: placebo intake; Procedure: Surgical resection of colonic adenocarcinoma stage III or II high risk; Biological: Molecular analysis of exon 9 and 20 of PI3K; Biological: blood intake

Interventions

Molecular analysis of exon 9 and 20 of PI3K BIOLOGICAL

Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece

Patient with aspirin intake; Patient with placebo intake

blood intake BIOLOGICAL

Blood intake will be done every 6 months to evaluate patient compliance to treatment

Patient with aspirin intake; Patient with placebo intake

aspirin intake DRUG

Patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years

Patient with aspirin intake

placebo intake DRUG

Patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years

Patient with placebo intake

Surgical resection of colonic adenocarcinoma stage III or II high risk PROCEDURE

Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines

Patient with aspirin intake; Patient with placebo intake

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Federation Francophone de Cancerologie Digestive: collaborator

Study Sites (1)

Rouen University Hospital

Rouen, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Pierre MICHEL, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre MICHEL, Pr

CONTACT

+3323288; pierre.michel@chu-rouen.fr

Julien BLOT

CONTACT

julien.blot@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 26, 2016
• Study Start: July 12, 2018
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

FR (1)