- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02945033
Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk (ASPIK French)
October 23, 2019 updated by: University Hospital, Rouen
French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
264
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pierre MICHEL, Pr
- Phone Number: 8265 +3323288
- Email: pierre.michel@chu-rouen.fr
Study Locations
-
-
-
Rouen, France
- Recruiting
- Rouen University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / 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
|
Patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years
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
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
|
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
Blood intake will be done every 6 months to evaluate patient compliance to treatment
Patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Time Frame: 5 years
|
5 years
|
|
Number of alive patient
Time Frame: 5 years
|
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
|
every 6 months during 3 years
|
Number of severe bleeding grade 3-4 events
Time Frame: 3 years
|
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
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2018
Primary Completion (Anticipated)
July 1, 2024
Study Completion (Anticipated)
July 1, 2024
Study Registration Dates
First Submitted
October 20, 2016
First Submitted That Met QC Criteria
October 24, 2016
First Posted (Estimate)
October 26, 2016
Study Record Updates
Last Update Posted (Actual)
October 24, 2019
Last Update Submitted That Met QC Criteria
October 23, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Colonic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- 2015/222/HP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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