Clinical Trial – Adjuvant Aspirin Treatment for Colon Cancer Patients – Colon Cancer

Following complete resection of their primary tumor, potentially eligible stage II or stage III colon cancer patients will undergo central PIK3CA testing. Patients with somatic mutations will be 2:1 randomized to daily aspirin 100 mg versus placebo for a total of 3 years or until disease recurrence, patient death or withdrawal of consent, whichever occurs first. Patients will be followed up for 10 years from the date of surgery.

The intake of aspirin or placebo is independent of adjuvant chemotherapy, and does not impact on the indication to give (or not to give) adjuvant chemotherapy.

Study Type  : Interventional  (Clinical Trial)
Estimated Enrollment  : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Adjuvant Aspirin Treatment in PIK3CA Mutated Colon Cancer Patients. A Randomized, Double-blinded, Placebo-controlled, Phase III Trial
Actual Study Start Date  : April 26, 2016
Estimated Primary Completion Date  : June 2019
Estimated Study Completion Date  : June 2029

Contacts
Contact: Karin Rotgiesser, PhD +41 31 389 91 91 trials@sakk.ch
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
European Organisation for Research and Treatment of Cancer – EORTC
Central European Society for Anticancer Drug Research
ClinicalTrials.gov Identifier: NCT02467582

 

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