There is a considerable body of pre-clinical, epidemiological and randomised data to support the hypothesis that aspirin has the potential to be an effective adjuvant cancer therapy.
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Add-Aspirin is a phase III, multi-centre, double-blind, placebo-controlled randomised trial with four parallel cohorts. Patients who have undergone potentially curative treatment for breast (n=3100), colorectal (n=2600), gastro-oesophageal (n=2100) or prostate cancer (n=2120) are registered into four tumour specific cohorts. All cohorts recruit in the United Kingdom, with the breast and gastro-oesophageal cohort also recruiting in India. Eligible participants first undertake an active run-in period where 100mg aspirin is taken daily for approximately eight weeks. Participants who are able to adhere and tolerate aspirin then undergo a double-blind randomisation and are allocated in a 1:1:1 ratio to either 100mg aspirin, 300mg aspirin or a matched placebo to be taken daily for at least five years. Those participants ≥75years old are only randomised to 100mg aspirin or placebo due to increased toxicity risk.
The primary outcome measures are invasive disease-free survival for the breast cohort, disease-free survival for the colorectal cohort, overall survival for the gastro-oesophageal cohort, and biochemical recurrence-free survival for the prostate cohort, with a co-primary outcome of overall survival across all cohorts. Secondary outcomes include adherence, toxicity including serious haemorrhage, cardiovascular events and some cohort specific measures.
The Add-Aspirin trial investigates whether regular aspirin use after standard therapy prevents recurrence and prolongs survival in participants with four non-metastatic common solid tumours.
Contemporary clinical trials. 2016 Oct 21 [Epub ahead of print]
Christopher Coyle, Fay H Cafferty, Samuel Rowley, Mairead MacKenzie, Lindy Berkman, Sudeep Gupta, C S Pramesh, Duncan Gilbert, Howard Kynaston, David Cameron, Richard H Wilson, Alistair Ring, Ruth E Langley, Add-Aspirin investigators
MRC Clinical Trials Unit, UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK., Independent Cancer Patient Voices, 17 Woodbridge Street, London EC1R 0LL, UK., NCRI Consumer Forum, Angel Building, 407 St John Street, London EC1V 4AD, UK., Room No. 1109, 11th Floor, Homi Bhabha Block, Tata Memorial Centre/Hospital, Parel, Mumbai 400012, India., Department of Surgical Oncology, Tata Memorial Centre, Dr Ernest Borges Marg, Parel, Mumbai 400012, India., MRC Clinical Trials Unit, UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK; Sussex Cancer Centre, Royal Sussex County Hospital, Eastern Road, Brighton, Sussex BN2 5BE, UK., Room 2F65, Block A2, Cardiff School of Medicine, Heath Park, Cardiff CF14 4XN, UK., Edinburgh Cancer Research Centre, University of Edinburgh, Western General Hospital, Crewe Road South, EH4 2XR, UK., Centre for Cancer Research and Cell Biology, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7AE, Northern Ireland, UK., The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey SM2 5PT, UK., MRC Clinical Trials Unit, UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK. Electronic address: .