ELIGIBILITY CRITERIA - COLON/RECTUM


COLON/RECTUM COHORT INCLUSION CRITERIA

  1. Histologically confirmed stage II or stage III (see appendix VII) adenocarcinoma of the colon or rectum and patients who have undergone resection of liver metastases with clear margins and no residual metastatic disease.
  2. Patients with synchronous tumours if one of the tumours is at least stage II or III.
  3. Serum CEA ideally ≤1.5 x upper limit of normal (ULN). Participants outside of this range can be discussed with the MRC CTU on an individual basis.
  4. Have undergone curative (R0) resection with clear margins (margins ≥1mm or as judged by the multidisciplinary team).
  5. Patients who have received standard neo-adjuvant and/or adjuvant treatment or therapy within an agreed trial. Timing of trial registration in terms of the treatment pathway should be as described in section 4.2 of the protocol. (For confirmation of standard therapy, please contact MRC CTU).
  6. No clinical or radiological evidence of residual or distant disease according to routine practice staging tests.
  7. Patients with known Lynch Syndrome are eligible, however CAPP3 trial should be offered in preference to Add-Aspirin if available. Patients that are not eligible for CAPP3 and patients that decline CAPP3 can be offered Add-Aspirin.
  8. Patients who are already participating (or have participated) in other primary treatment trials may be eligible but this must be agreed in advance with the relevant trial teams. Trials where there is already an agreement in place are listed below in section 4.4.2 of the protocol. If a potential participant is enrolled in a trial that is not listed, this should be discussed with the MRC CTU prior to registration.
  9. WHO performance status 0, 1 or 2.
  10. Written informed consent.

COLON/RECTUM COHORT EXCLUSION CRITERIA

  1. Proven (or clinically suspected) metastatic disease (patients who have undergone resection of liver metastases with clear margins and no residual metastatic disease are eligible).
  2. Current or previous regular use of aspirin (at any dose) or current use of another NSAID for any indication (see appendix IV for list of medications not permitted in the trial).
    • a. Regular aspirin use is defined as taking aspirin more than twice in any given week for more than 4 consecutive weeks.
    • b. Current NSAID use is defined as taking any NSAID for more than a week in the preceding month. If investigators feel that this definition may unfairly exclude a participant, this can be discussed with the MRC CTU and a case by case decision will be made.
  3. A past history of adverse reaction/hypersensitivity to NSAIDs, celecoxib, aspirin or other salicylates or sulphonamides, including asthma that is exacerbated by use of NSAIDs.
  4. Current use of anti-coagulants.
  5. Current or long-term use of oral corticosteroids. The treating physician should make the clinical decision whether a patient has been exposed to long-term therapy.
  6. Active or previous peptic ulceration or gastrointestinal bleeding within the last year, except where the cause of the bleeding has been surgically removed.
  7. Active or previous history of inflammatory bowel disease.
  8. History of moderate or severe renal impairment, with eGFR<45ml/min/1.73m2.
  9. Previous invasive or non-invasive malignancy except:
    • a. DCIS where treatment consisted of resection alone.
    • b. Cervical carcinoma in situ where treatment consisted of resection alone.
    • c. Basal cell carcinoma where treatment consisted of resection alone or radiotherapy.
    • d. Superficial bladder carcinoma where treatment consisted of resection alone.
    • e. Other cancers where the patient has been disease-free for ≥15 years.
  10. Any other physical condition which is associated with increased risk of aspirin-related morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including but not limited to severe asthma, haemophilia and other bleeding diatheses, macular degeneration and patients with a high risk of mortality from another cause within the trial treatment period.
  11. Known G6PD deficiency.
  12. Known lactose intolerance.
  13. LFTs greater than 1.5x the upper limit of normal unless the participant has been discussed with the MRC CTU and the TMG agrees that they are suitable for the trial. This will be decided on a case-by-case basis.
  14. Anticipated difficulties in complying with trial treatment or follow-up schedules.
  15. <16 years old in the UK or <18 years old in India.
  16. Participants in other treatment trials where this has not been agreed in advance by both trial teams. Specific trials where a second randomisation has already been agreed with the relevant trial teams are indicated in section 4.4.2 of the protocol. For all other trials, this should be discussed with the Trial Managers at the MRC CTU in the first instance.
  17.  Pregnant or breast feeding, or intending to become pregnant or breast feed during the trial treatment period. Participants should agree to inform the trial team if they subsequently become pregnant, or plan to become pregnant, whilst they are still receiving treatment in the trial (see section 5.4.4 of the protocol).


The trial is being jointly funded by Cancer Research UK (grant number C471 /A15015, www.cancerresearchuk.org), the National Institute for Health Research Health Technology Assessment Programme (project number 12/01/38, www.nihr.ac.uk) and the MRC Clinical Trials Unit at UCL.
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