Evaluation of the efficacy of low-dose aspirin on the recurrence of the disease in people recently operated for colon cancer

PRODIGE 50 - ASPIK : French prospective randomised double blind study on aspirin versus placebo in resected colon cancer with PI3K mutation stage III or II high risk - PRODIGE 50 - ASPIK FRENCH

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002209-20-FR

Enrollment

264

Registered

2016-11-22

Start date

2016-08-19

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mutated PI3K colonic adenocarcinoma patients with surgical resection R0

Interventions

Trade Name: ASPIRINE PROTECT 100 mg Pharmaceutical Form: Pillules INN or Proposed INN: ACETYLSALICYLIC ACID CAS Number: 50-78-2 Concentration unit: mg milligram(s) Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Colonic adenocarcinoma stage III 3. Colonic adenocarcinoma stage II high risk MSS: a. T4bN0 or T4a tumour penetrating the surface of the visceral peritoneum; b. or less than 12 nodes evaluated; c. 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). 4. PI3K mutation, exon 9 or 20 (tumour) 5. Resection R0 6. WHO performance status 0-2 7. Chest and abdominal CT scan = 8 weeks 8. Life expectancy = 3 years 9. Written consent signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 102 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 62

Exclusion criteria

Exclusion criteria: 1. Anticoagulant and/or Antiaggregating treatment including clopidogrel 2. Regular aspirin use (> 3 doses per week during more than 3 months the last year) 3. Follow-up of the patient not feasible 4. Contraindication to Aspirin : a. Active or antecedent peptic ulcer b. Allergy to aspirin 5. Severe renal or hepatic insufficiency 6. Pregnancy or nursing ongoing 7. Rectal cancer 8. Hereditary forms (i.e. lynch syndrome patients)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the effectiveness of aspirin on the disease-free survival at 3 years after curative surgery for colonic adenocarcinoma with PI3K mutation.;Secondary Objective: -Disease-free survival at 5 years -Overall survival at 5 years -Compliance to aspirin (Thromboxane B2 measurements and comptability of containers) -Severe bleeding grade 3-4 events and hospitalization according to NCI-CTC grading 4.0 -Adverse event reported and graded according to NCI-CTC grading 4.0 ;Primary end point(s): The objective is to demonstrate a reduction of 44% on the disease-free survival(DFS) rate at 3 years. DFS is defined as the time from date of randomization to date of first local or distant recurrence, or second colorectal cancer, or death (from any cause), whichever occurred first. ;Timepoint(s) of evaluation of this end point: 3 years after the inclusion of the last patient	—

Measure

Time frame

Main Objective: The primary objective is to assess the effectiveness of aspirin on the disease-free survival at 3 years after curative surgery for colonic adenocarcinoma with PI3K mutation.;Secondary Objective: -Disease-free survival at 5 years -Overall survival at 5 years -Compliance to aspirin (Thromboxane B2 measurements and comptability of containers) -Severe bleeding grade 3-4 events and hospitalization according to NCI-CTC grading 4.0 -Adverse event reported and graded according to NCI-CTC grading 4.0 ;Primary end point(s): The objective is to demonstrate a reduction of 44% on the disease-free survival(DFS) rate at 3 years. DFS is defined as the time from date of randomization to date of first local or distant recurrence, or second colorectal cancer, or death (from any cause), whichever occurred first. ;Timepoint(s) of evaluation of this end point: 3 years after the inclusion of the last patient

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are : - Disease-free survival at 5 years - Overall survival at 5 years - Compliance to aspirin (Thromboxane B2 measurements and comptability of containers) - Severe bleeding grade 3-4 events and hospitalization according to NCI-CTC grading 4.0 - Adverse event reported and graded according to NCI-CTC grading 4.0;Timepoint(s) of evaluation of this end point: 5 years after the inclusion of the last patient	—

Measure

Time frame

Secondary end point(s): Secondary endpoints are : - Disease-free survival at 5 years - Overall survival at 5 years - Compliance to aspirin (Thromboxane B2 measurements and comptability of containers) - Severe bleeding grade 3-4 events and hospitalization according to NCI-CTC grading 4.0 - Adverse event reported and graded according to NCI-CTC grading 4.0;Timepoint(s) of evaluation of this end point: 5 years after the inclusion of the last patient

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Countries

France

Contacts

Public ContactJérémie BEZ

Fédération Francophone de Cancérologie Digestive (FFCD)

jeremie.bez@u-bourgogne.fr33380393483

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026