Spots Global Cancer Trial Database for Finding the Best Dose of Aspirin to Prevent Lynch Syndrome Cancers

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Trial Identification

Brief Title: Finding the Best Dose of Aspirin to Prevent Lynch Syndrome Cancers

Official Title: A Randomised Double Blind Dose Non-inferiority Trial of a Daily Dose of 600mg Versus 300mg Versus 100mg of Enteric Coated Aspirin as a Cancer Preventive in Carriers of a Germline Pathological Mismatch Repair Gene Defect, Lynch Syndrome

Study ID: NCT02497820

Conditions

Lynch Syndrome I (Site-specific Colonic Cancer)

Interventions

Aspirin

Study Description

Brief Summary: A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention Programme (CaPP3).

Detailed Description: Study design: A randomised, double-blind, dose non-inferiority study. Study Intervention: Enteric-coated aspirin 100mg, 300mg or 600mg blinded dose daily followed by daily 100mg open label dose daily. Primary objective: To determine whether the cancer preventive properties of enteric coated aspirin in Lynch syndrome are dose sensitive by comparing overall cumulative Lynch syndrome cancer incidence rates after 5 years in people who took 100mg, 300mg or 600mg enteric coated aspirin for at least 2 years. Secondary objectives: Compare overall cumulative incidence of primary colorectal cancers using Poisson regression to allow for multiple primaries in individual patients in the three treatment groups. Compare overall cumulative incidence of primary endometrial cancers using Poisson regression to allow for multiple primaries in individual patients in the three treatment groups. Compare overall cumulative incidence of cancers of all types, using Poisson regression to allow for multiple primaries in individual patients in the three treatment groups. The burden of adverse events associated with the different aspirin doses in this relatively young and healthy population will be documented. Primary outcome: The number of new primary mismatch repair deficient cancers ("Lynch syndrome cancers") at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years. Number of study sites: 4 ISRAEL sites. 20 sites all over the world. Study population/size: 300 patients in ISRAEL. UK 1000-1500 patients. Total with International 3,000 patients. Study duration: 7 years.