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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 : Not yet recruiting
First Posted : October 26, 2016
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
Federation Francophone de Cancerologie Digestive
Information provided by (Responsible Party):
University Hospital, Rouen

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: aspirin intake 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 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
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
Drug: aspirin intake
Patient with colonic adenocarcinoma stage III or II high risk will take 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

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
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




Primary Outcome Measures :
  1. 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 Measures :
  1. Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first [ Time Frame: 5 years ]
  2. Number of alive patient [ Time Frame: 5 years ]
  3. 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

  4. Number of severe bleeding grade 3-4 events [ Time Frame: 3 years ]
  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945033


Contacts
Contact: Pierre MICHEL, Pr +3323288 ext 8265 pierre.michel@chu-rouen.fr
Contact: Julien BLOT julien.blot@chu-rouen.fr

Locations
France
Rouen University Hospital Not yet recruiting
Rouen, France
Principal Investigator: Pierre MICHEL, Pr         
Sponsors and Collaborators
University Hospital, Rouen
Federation Francophone de Cancerologie Digestive
Investigators
Principal Investigator: Pierre MICHEL, Pr Rouen University Hospital

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02945033     History of Changes
Other Study ID Numbers: 2015/222/HP
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Rouen:
Pi3k mutation
Aspirin

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics