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

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ClinicalTrials.gov Identifier: NCT02945033
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : October 24, 2019
Sponsor:
Collaborator:
Federation Francophone de Cancerologie Digestive
Information provided by (Responsible Party):
University Hospital, Rouen

Tracking Information
First Submitted Date  ICMJE October 20, 2016
First Posted Date  ICMJE October 26, 2016
Last Update Posted Date October 24, 2019
Actual Study Start Date  ICMJE July 12, 2018
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02945033 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
  • Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first [ Time Frame: 5 years ]
  • Number of alive patient [ Time Frame: 5 years ]
  • Number of pills taken by the patient for compliance evaluation [ Time Frame: every 6 months during 3 years ]
    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 [ Time Frame: 3 years ]
  • Number of participants with treatment-related adverse events [ Time Frame: 3 years ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk
Official Title  ICMJE French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: aspirin intake
    Patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years
  • Drug: placebo intake
    Patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years
  • Procedure: 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
  • Biological: Molecular analysis of exon 9 and 20 of PI3K
    Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece
  • Biological: blood intake
    Blood intake will be done every 6 months to evaluate patient compliance to treatment
Study Arms  ICMJE
  • Experimental: 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
    Interventions:
    • 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
  • Placebo Comparator: 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
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 24, 2016)
264
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pierre MICHEL, Pr +3323288 ext 8265 pierre.michel@chu-rouen.fr
Contact: Julien BLOT julien.blot@chu-rouen.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02945033
Other Study ID Numbers  ICMJE 2015/222/HP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Rouen
Study Sponsor  ICMJE University Hospital, Rouen
Collaborators  ICMJE Federation Francophone de Cancerologie Digestive
Investigators  ICMJE
Principal Investigator: Pierre MICHEL, Pr Rouen University Hospital
PRS Account University Hospital, Rouen
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP