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

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
aspirin intake
placebo intake
Surgical resection of colonic adenocarcinoma stage III or II high risk
Molecular analysis of exon 9 and 20 of PI3K
blood intake
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Pi3k mutation, Aspirin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rouen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Patient with aspirin intake

Patient with placebo intake

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2016
Last Updated
October 23, 2019
Sponsor
University Hospital, Rouen
Collaborators
Federation Francophone de Cancerologie Digestive
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1. Study Identification

Unique Protocol Identification Number
NCT02945033
Brief Title
Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk
Acronym
ASPIK French
Official Title
French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
Collaborators
Federation Francophone de Cancerologie Digestive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Pi3k mutation, Aspirin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with aspirin intake
Arm Type
Experimental
Arm Description
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
Arm Title
Patient with placebo intake
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
aspirin intake
Intervention Description
Patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years
Intervention Type
Drug
Intervention Name(s)
placebo intake
Intervention Description
Patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years
Intervention Type
Procedure
Intervention Name(s)
Surgical resection of colonic adenocarcinoma stage III or II high risk
Intervention Description
Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines
Intervention Type
Biological
Intervention Name(s)
Molecular analysis of exon 9 and 20 of PI3K
Intervention Description
Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece
Intervention Type
Biological
Intervention Name(s)
blood intake
Intervention Description
Blood intake will be done every 6 months to evaluate patient compliance to treatment
Primary Outcome Measure Information:
Title
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Time Frame
5 years
Title
Number of alive patient
Time Frame
5 years
Title
Number of pills taken by the patient for compliance evaluation
Description
Number of pills taken by the patient will be assess in order to evaluate patient's compliance
Time Frame
every 6 months during 3 years
Title
Number of severe bleeding grade 3-4 events
Time Frame
3 years
Title
Number of participants with treatment-related adverse events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre MICHEL, Pr
Phone
+3323288
Ext
8265
Email
pierre.michel@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre MICHEL, Pr
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre MICHEL, Pr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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