MedTrace Logo

A Randomized, 2x2 Factorial Design Biomarker Prevention Trial of Low-dose ASA and Metformin in Stage I-III Crc Patients

NCT03047837 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-01-27

No results posted yet for this study

Summary

It has been shown that Aspirin (ASA) as well as Metformin (Met) can inhibit the incidence and mortality of colorectal cancer (CRC). In this randomized, placebo controlled clinical trial we compare the effect of these two drugs alone and their combination to prevent recurrent CRC after surgery.

Conditions

  • Tertiary Prevention in Colon Cancer

Interventions

DRUG

ASA

Arm C (experimental arm) Treatment: active ASA + placebo MET Dose: 100 mg, 1 tablet daily + 1 tablet twice a day (BID) Duration: 12 months

DRUG

MET

Arm B (experimental arm) Treatment: placebo ASA + active MET Dose: 1 tablet daily+ 850 mg, 1 tablet twice a day (BID) Duration: 12 months

OTHER

Placebo

Arm A (control arm) Treatment: placebo ASA + placebo MET Doses: 1 tablet daily +1 tablet twice a day (BID) Duration: 12 months

Sponsors & Collaborators

  • Ente Ospedaliero Ospedali Galliera

    lead OTHER

Principal Investigators

  • Andrea De Censi, MD · E.O. Ospedali Galliera

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-15
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03047837 on ClinicalTrials.gov