None listed
Conditions
Brief summary
This study will evaluate the safety and efficacy of adjuvant Aspirin 200mg versus Placebo 200mg for patients with Dukes C colon cancer, high risk Dukes B colon cancer, Dukes B rectal cancer or Dukes C rectal cancer patients. Who is it for? You may be eligible for this study if you are aged 18 years or above, and have confirmed Dukes C colon cancer, high risk Dukes B rectal cancer or Dukes C rectal cancer for which you have had surgery to remove the primary tumour and completed at least 3 months of chemotherapy. Study details Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will be provided with Aspirin 200mg daily for 3 years and the other group will be provided with a matching Placebo 200mg daily for 3 years. Participants will be asked to attend clinic visits every 3 months for a period of 3 years and thereafter every 6 months for 2 years to determine disease free survival, overall survival and quality of life.
Interventions
Eligible participants will be randomised to the study in 1:1 ration to either Aspirin arm: 200 mg Aspirin (oral tablet) once a day for 3 years or Placebo equivalent.
The study treatment is given as adjuvant therapy
Drug compliance will be monitored via drug dispensations and drug returns, recorded on drug accountability logs at each study visit.
Noncompliance is defined as omission of more than 30% of the study period that the patient is on the study.
Sponsors
Australasian Gastro-Intestinal Trial Group (AGITG)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Male or female outpatient of at least 18 years of age or at least the country's legal age for adult consent - Dukes C colon cancer, high risk Dukes B colon cancer, Dukes B rectal cancer or Dukes C rectal cancer - Undergone complete resection of primary tumour - Completed standard therapy (at least 3 months of chemotherapy with or without radiotherapy) - Within 120 days of completion of standard therapy (surgery, chemotherapy with or without radiotherapy) - ECOG performance status 0 to 2 - Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation): Results of clinical investigations carried out within 8 weeks prior to randomisation can be used in place of the required screening investigations. Patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ASCOLT Trial Management GroupB-F57 - ANC greater than or equal to 1.0 x 109/L - Platelets greater than or equal to 100 x 109/L - Creatinine clearance greater than or equal to 30 mL/min - Total bilirubin less than or equal to 2.0 x the upper limit normal - AST & ALT less than or equal to 5 x the upper limit normal - Completed the following investigations - Colonoscopy (or CT colonogram) within 16 months prior to randomization - Imaging of abdomen (CT or CT colonogram or MRI or PET or Ultrasound) within 16 months prior to randomization - Written informed consent
Exclusion criteria
- Pre-existing Familial adenomatous polyposis, inflammatory bowel disease or ulcerative colitis - Active gastritis or active peptic ulcer - History of continuous daily use of PPI more than 1 year prior to consent - Gastrointestinal bleeding within the past one year - Haemorrhagic diathesis (i.e. haemophilia) - Uncontrolled hypertension (untreated systolic blood pressure > 160 mmHg, or diastolic blood pressure > 95 mmHg) - History of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years - History of stroke, coronary arterial disease, angina, or vascular disease - Patients who are on current long term treatment (greater than or equal to 4 consecutive weeks) with Aspirin, NSAID or Cox-2 inhibitors - History of erosive GERD or active erosive GERD on gastroscopy. - Patient on active current treatment of antiplatelet agents (i.e. off-study Aspirin, clopidogrel, ticlopidine) - Patient receiving active treatment of anticoagulants (i.e. warfarin, low molecular weight heparins) - Pregnant, lactating, or not using adequate contraception - Patient having known allergy to NSAID or Aspirin - Unexplained rise of CEA (i.e. smoker with elevated CEA will not be excluded) - Patient on other investigational drug - Patients with HNPCC (Lynch Syndrome)
Outcome results
None listed