Add-Aspirin

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  120104

• Contact email

  mrcctu.add-aspirin@ucl.ac.uk

• Sponsor organisation

  Medical Research Council Clinical Trials Unit at UCL

• Eudract number

  2013-004398-28

• ISRCTN Number

  n/a

• Research summary

  Add-Aspirin is a large clinical trial for people who have had treatment for breast, colorectal, gastro-oesophageal or prostate cancer. The aim of the trial is to find out whether taking aspirin regularly after treatment for early stage cancer stops or delays the cancer coming back.
  Participants will self-administer 100mg aspirin once daily for 8 weeks. After 8 weeks, if taking regular aspirin does not cause any serious problems, participants will be randomly allocated to self-administer either a 300mg aspirin tablet, a 100mg aspirin tablet or a placebo tablet once daily for at least five years. Participants who are 75 years old or over, will only be allocated to 100mg aspirin tablets daily or placebo tablets. To ensure the results of the trial are as reliable as possible, neither the participants, nor the clinicians will know which tablets participants are allocated to.
  In total, 9,920 participants will be randomised into the trial over 3 – 6 years (depending on tumour site). All participants will be followed-up within the trial for at least 5 years. In the UK, long-term follow-up data will also be obtained from routinely-collected healthcare databases.
  A programme of associated correlative science is planned incorporating both short- and long-term projects which will investigate key questions including: determining the mechanism of action for an anti-cancer effect of aspirin; determining biomarkers that identify participants most likely to experience serious aspirin-related toxicity; determining the roles of genotypic and phenotypic differences in aspirin’s actions; identifying individuals who will benefit most or least from aspirin and determining the mechanisms underlying potential non-cancer benefits of aspirin.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  14/SC/0171

• Date of REC Opinion

  4 Jun 2014

• REC opinion

  Further Information Favourable Opinion