Lynch Syndrome I (Site-specific Colonic Cancer) Clinical Trial
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
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).
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention