Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Adjuvant Therapy
  • Colon Cancer
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 45 years and 125 years
Gender
Both males and females

Description

The purpose of this study is to determine the effect of 80mg acetylsalicylic acid (given orally once daily for 5 years) on 5 year overall survival (OS) for stage II and III colon cancer patients of 45 years of age and older. Preclinical, epidemiologic and clinical evidence suggest that acetylsalicyl...

The purpose of this study is to determine the effect of 80mg acetylsalicylic acid (given orally once daily for 5 years) on 5 year overall survival (OS) for stage II and III colon cancer patients of 45 years of age and older. Preclinical, epidemiologic and clinical evidence suggest that acetylsalicylic acid use may reduce overall cancer risk and mortality in colon cancer patients. It is a phase III double blind placebo controlled, randomized trial of adjuvant low-dose acetylsalicylic acid in colon cancer patients. Patients will be stratified at randomization by centre, age (<70 and ≥70 years) chemotherapy use (any versus none) and disease stage.

Tracking Information

NCT #
NCT02301286
Collaborators
  • Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS)
  • Dutch Colorectal Cancer Group
  • Stichting Geriatrische Oncologie Nederland (GeriOnNe)
  • Fonds NutsOhra
  • Innovatiefonds Zorgverzekeraars
Investigators
Principal Investigator: G.J. Liefers, MD PhD Leiden University Medical Center Principal Investigator: J.E.A. Portielje, Professor Leiden University Medical Center Principal Investigator: R. Fodde, Professor Erasmus Medisch Centrum
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