title: ADD-ASPIRIN: A phase III, double-blind, placebo controlled, randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours.
abstract: 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.
  
  
  
  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.
authors: MRC Clinical Trials Unit, UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK.
authors: Christopher
authors: C
authors: Coyle
authors: MRC Clinical Trials Unit, UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK.
authors: Fay H
authors: FH
authors: Cafferty
authors: MRC Clinical Trials Unit, UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK.
authors: Samuel
authors: S
authors: Rowley
authors: Independent Cancer Patient Voices, 17 Woodbridge Street, London EC1R 0LL, UK.
authors: Mairead
authors: M
authors: MacKenzie
authors: NCRI Consumer Forum, Angel Building, 407 St John Street, London EC1V 4AD, UK.
authors: Lindy
authors: L
authors: Berkman
authors: Room No. 1109, 11th Floor, Homi Bhabha Block, Tata Memorial Centre/Hospital, Parel, Mumbai 400012, India.
authors: Sudeep
authors: S
authors: Gupta
authors: Department of Surgical Oncology, Tata Memorial Centre, Dr Ernest Borges Marg, Parel, Mumbai 400012, India.
authors: C S
authors: CS
authors: Pramesh
authors: 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.
authors: Duncan
authors: D
authors: Gilbert
authors: Room 2F65, Block A2, Cardiff School of Medicine, Heath Park, Cardiff CF14 4XN, UK.
authors: Howard
authors: H
authors: Kynaston
authors: Edinburgh Cancer Research Centre, University of Edinburgh, Western General Hospital, Crewe Road South, EH4 2XR, UK.
authors: David
authors: D
authors: Cameron
authors: Centre for Cancer Research and Cell Biology, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7AE, Northern Ireland, UK.
authors: Richard H
authors: RH
authors: Wilson
authors: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey SM2 5PT, UK.
authors: Alistair
authors: A
authors: Ring
authors: MRC Clinical Trials Unit, UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK. Electronic address: ruth.langley@ucl.ac.uk.
authors: Ruth E
authors: RE
authors: Langley
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D001241:Aspirin / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy; D018572:Disease-Free Survival; D004311:Double-Blind Method; D004342:Drug Hypersensitivity / Q000209:etiology; D004938:Esophageal Neoplasms / Q000188:drug therapy; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced; D006801:Humans; D007194:India / Q000453:epidemiology; D020300:Intracranial Hemorrhages / Q000139:chemically induced; D008137:Longitudinal Studies; D008268:Macular Degeneration / Q000139:chemically induced; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000453:epidemiology*; D009369:Neoplasms / Q000188:drug therapy*; D010437:Peptic Ulcer / Q000139:chemically induced; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy; D013274:Stomach Neoplasms / Q000188:drug therapy; D015996:Survival Rate; D014012:Tinnitus / Q000139:chemically induced; D006113:United Kingdom / Q000453:epidemiology
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D001241:Aspirin
keywords: Aspirin; Breast cancer; Colorectal cancer; Gastro-oesophageal cancer; Prostate cancer; Randomised controlled trial