Title
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A randomised clinical trial to assess the effects of aspirin versus placebo on disease recurrence and survival after primary therapy in common non-metastatic solid tumors.. (Add Aspirin Study). Study design / Type : Double-blind randomised controlled trial |
Investigators
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Dr. C S Pramesh |
Participating Centres
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Number of participants
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Breast Cohort: 900 Gastroesophageal Cohort: 750 Colorectal Cohort :200 Prostate Cohort: 150 |
Status
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Ongoing |
Synopsis
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To assess whether regular aspirin use after standard therapy prevents recurrence and prolongs survival in participants with non-metastatic common solid tumours. Standard therapy includes radical surgery or radiotherapy plus any adjuvant or neo-adjuvant therapy, or participation in any pre-approved trials.
Participants will be randomly assigned to 100mg aspirin, 300mg aspirin or matched placebo. All tablets will be enteric-coated to be taken daily for at least five years. During the feasibility phase of the study, all participants will take open label 100mg aspirin daily fora run-in period of approximately 8 weeks prior to randomisation. Primary Outcome measures: All participants: overall survival Breast cancer: invasive disease-free survival Colorectal cancer: disease-free survival Gastro-oesophageal cancer: overall survival Prostate cancer: biochemical recurrence-free survival |