Clinical Trial: NCT02945033 - My Cancer Genome

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:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02945033

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

Drug	Synonyms	Arms
aspirin intake		Patient with aspirin intake
placebo intake		Patient with placebo intake
Molecular analysis of exon 9 and 20 of PI3K		Patient with aspirin intake
blood intake		Patient with aspirin intake

Purpose

Trial Arms

Name	Type	Description	Interventions
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	aspirin intake Molecular analysis of exon 9 and 20 of PI3K 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	placebo intake Molecular analysis of exon 9 and 20 of PI3K blood 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:	Recruiting
Lead Sponsor:	University Hospital, Rouen

Trial Keywords

Pi3k mutation
Aspirin

Last Updated

October 24, 2019

Clinical Trials /

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