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

Colorectal Cancer Clinical Trial

— ASPIK French  

Official title:

French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02945033
• Other study ID #: 2015/222/HP
• Status: Recruiting
• Phase: Phase 3
• Start date: July 12, 2018
• Est. completion date: July 2024

Study information

• Verified date: October 2019
• Source: University Hospital, Rouen
• Contact: Pierre MICHEL, Pr
• Phone: +3323288
• Email: pierre.michel[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer

Intervention

Drug:
• aspirin intake
Patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years
• 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
• blood intake
Blood intake will be done every 6 months to evaluate patient compliance to treatment

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	Federation Francophone de Cancerologie Digestive

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first		3 years
Secondary	Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first		5 years
Secondary	Number of alive patient		5 years
Secondary	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	every 6 months during 3 years
Secondary	Number of severe bleeding grade 3-4 events		3 years
Secondary	Number of participants with treatment-related adverse events	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	3 years