Clinical Trials /

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

NCT02945033

Description:

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.

Related Conditions:
  • Colon Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 2015/222/HP
  • NCT ID: NCT02945033

Conditions

  • Colorectal Cancer

Interventions

DrugSynonymsArms
aspirin intakePatient with aspirin intake
placebo intakePatient with placebo intake
Molecular analysis of exon 9 and 20 of PI3KPatient with aspirin intake
blood intakePatient with aspirin intake

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Patient with aspirin intakeExperimentalSurgical 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
  • aspirin intake
Patient with placebo intakePlacebo ComparatorSurgical 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
  • placebo intake

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Time Frame:3 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Time Frame:5 years
Safety Issue:
Description:
Measure:Number of alive patient
Time Frame:5 years
Safety Issue:
Description:
Measure:Number of pills taken by the patient for compliance evaluation
Time Frame:every 6 months during 3 years
Safety Issue:
Description:Number of pills taken by the patient will be assess in order to evaluate patient's compliance
Measure:Number of severe bleeding grade 3-4 events
Time Frame:3 years
Safety Issue:
Description:
Measure:Number of participants with treatment-related adverse events
Time Frame:3 years
Safety Issue:
Description:Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University Hospital, Rouen

Trial Keywords

  • Pi3k mutation
  • Aspirin

Last Updated