The ASPIRIN trial is a phase III double-blind placebo-controlled randomised trial of aspirin on recurrence and survival in colon cancer patients.
The objective is to investigate acetylsalicylic acid 80 mg po daily for 5 years as an adjuvant therapy in curatively operated, stage II and III colon cancer patients. The question will be addressed by means of two parallel studies in patients with and without adjuvant chemotherapy.
The ASPIRIN trial is supported by the Dutch Colorectal Cancer Group (DCCG), the Dutch Surgical Colorectal Audit (DSCA) for efficient data collection, Gerionne, Patiëntengroep Darmkanker Nederland, Innovatiefonds, Nuts Ohra and the Anticancer Fund.
- Protocol v2.4
- Pharmacy Protocol v2.3
- Randomisation Manual v2.3
- Data Entry Manual v1.2
- Randomisation Form v2.2
- CRF Total June 2016
- CRF Instructions v2.1
- Patient Information v2.0 (In Dutch, site specific version can be requested at the Datacenter)
See also the DCCG Trials app in the Google Play store or iTunes
Rationale: Preclinical, epidemiologic and clinical evidence suggest that acetylsalicylic acid use may reduce overall cancer risk and mortality in colon cancer patients.
Objective: To investigate acetylsalicylic acid 80 mg po daily for 5 years as an adjuvant therapy in curatively operated, stage II and III colon cancer patients.
Study design: A phase III double-blind placebo-controlled randomised trial of adjuvant low-dose acetylsalicylic acid in colon cancer patients. The question will be addressed by means of two parallel studies in patients treated with or without adjuvant chemotherapy.
- Patients 45 years and older with histologically confirmed adenocarcinoma of the colon
- Patients must have TNM stage that is one of the following: pT3-4; N0-2 and M0, or pT1-2 and N1-2 (UICC stage II and III) (in case of >1 tumour: more advanced tumour is stage II or III)
- Patients must have completed surgical resection (R0) (both laparoscopic and open surgery) within 12 weeks of randomisation
- Patients with rectal cancer (defined as tumour within 15 cm from the anal verge)
- Patients currently taking oral anti-coagulants or use of LMWH
- Patients currently taking acetylsalicylic acid for any reason
- Patients with a history of bleeding disorders or active gastric or duodenal ulcers
- Patients currently taking high dose systemic glucocorticoids (≥ 30 mg predniso(lo)n or equivalent)
- Patients with (suspected) (non-) polyposis syndrome (FAP/AFAP, MAP, Lynch syndrome)
- Patients with >100 polyps of the colon or a known hereditary syndrome of the colon in a first degree family member
- Allergy or intolerance to salicylates
- Patients with local or distant recurrent disease
- Previous malignancies other than CIN, BCC or SCC with a disease free survival less than 5 years
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Patients will be randomised for acetylsalicylic acid 80 mg po daily for 5 years versus placebo.
Main study parameters/endpoints: The primary endpoint of the trial is 5 year Overall Survival (5-yr OS). Secondary endpoints are Time to Treatment Failure (TTF; time elapsed between randomisation until treatment discontinuation due to disease recurrence, unacceptable toxicity, death or any other event of interest) and 3-year Disease Free Survival (DFS); time to recurrence or death due to any cause. The trial is powered to identify a hazard ratio of 0.75 in the acetylsalicylic acid arm, with 80 percent power and a type 1 error of 0.05 (2-sided). In order for the trial to be successful, 1588 patients need to be randomised.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Unexpected adverse events may occur. Given the widespread use of low dose acetylsalicylic acid in cardiovascular risk management, it is unlikely that new toxicities will be identified. However, adverse anti-cancer effects may be identified. An independent data safety monitoring board will oversee trial conduct. A planned interim futility analysis allows early termination of the study if it appears that acetylsalicylic acid will not favourably impact colon cancer outcome.
Page last updated on 01-07-2020