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

NCT ID: NCT02945033

Last Updated: 2019-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2024-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Patient with aspirin intake

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

Group Type: EXPERIMENTAL

aspirin intake

Intervention Type: DRUG

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

Surgical resection of colonic adenocarcinoma stage III or II high risk

Intervention Type: PROCEDURE

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

Intervention Type: BIOLOGICAL

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

blood intake

Intervention Type: BIOLOGICAL

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

Patient with placebo intake

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

Group Type: PLACEBO_COMPARATOR

placebo intake

Intervention Type: DRUG

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

Surgical resection of colonic adenocarcinoma stage III or II high risk

Intervention Type: PROCEDURE

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

Intervention Type: BIOLOGICAL

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

blood intake

Intervention Type: BIOLOGICAL

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

Interventions

aspirin intake

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

Intervention Type: DRUG

placebo intake

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

Intervention Type: DRUG

Surgical 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

Intervention Type: PROCEDURE

Molecular analysis of exon 9 and 20 of PI3K

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

Intervention Type: BIOLOGICAL

blood intake

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federation Francophone de Cancerologie Digestive

OTHER

Sponsor Role: collaborator

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre MICHEL, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Rouen University Hospital

Rouen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pierre MICHEL, Pr

Role: CONTACT

pierre.michel@chu-rouen.fr

+3323288 ext. 8265

Julien BLOT

Role: CONTACT

julien.blot@chu-rouen.fr

Other Identifiers

2015/222/HP

Identifier Type: -

Identifier Source: org_study_id