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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

 Dr. C S Pramesh
Participating Centres
  1. Tata Memorial Hospital, Mumbai
  2. Cancer Institute, Adayar (WIA), Chennai
  3. Basavatarakam Indo-American Cancer Hospital, Hyderabad
  4. Tata Medical Centre. Kolkata
  5. Regional Cancer Centre, Trivandrum
  6. Chennai Breast Centre, Chennai
  7. Jehangir Clinical Development Center, Pune
  8. Max Super Speciality Hospital, New Delhi
  9. Cachar Cancer Hospital and Research Centre , Silchar
  10. Jawaharlal Institute of Postgraduate Medical Education & Research, Pondicherry
  11. Thangam Hospital and Cancer Center, Namakkal.
Number of participants

        Breast Cohort: 900

        Gastroesophageal Cohort: 750

        Colorectal Cohort :200

        Prostate Cohort: 150
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

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