Colorectal Cancer
Conditions
Keywords
stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer
Brief summary
We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in this patient population over placebo control. If indeed found to be beneficial, because aspirin is cheap and easy to administer, it will positively impact the lives of many individuals in Asia and globally. STUDY OBJECTIVE To assess the effectiveness of Aspirin against placebo control in patients with dukes C or high risk dukes B colorectal cancer in terms of Disease Free Survival (DFS) and Overall Survival (OS) Primary endpoints * DFS among all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer patient sub-groups); * DFS among patients with colon cancer (high-risk Dukes B and Dukes C colon cancer). Secondary endpoints * Overall survival (OS) over 5 years * DFS and OS in * Chinese, Malay, Indian and other ethnic groups * Resected high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer sub-groups, individually * Compliant versus non-compliant subjects * PIK3CA mutated tumors (where samples are available)
Detailed description
Aspirin in patients with dukes C or high risk dukes B colorectal cancer can improve survival in this patient population over placebo control. Eligible patients will be randomized to treatment arms, using the following stratification factors: * Study Centre * Tumour Type * Type of adjuvant chemotherapy received(exposed/not exposed to oxaliplatin Patients will be randomized over a 5 years' time period. After randomization, patient will have 3 monthly assessments with treatment for 3 years followed by 6 monthly assessments for additional 2 years follow-up
Interventions
OTHERplacebo
Placebo Comparator
DRUGAcetylsalicylic acid
Adjuvant Therapy
Sponsors
Australasian Gastro-Intestinal Trials Group
INDOX Cancer Research Network
University of Sydney
National Cancer Centre, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female outpatient of ≥ 18 years of age or ≥ 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 (see Appendix 1 for definition of High Risk Dukes B) * Undergone complete resection of primary tumour * Completed standard therapy ( at least 3 months of chemotherapy ± radiotherapy ) * Within 120 days of completion of standard therapy (surgery, chemotherapy ± 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 Group * ANC ≥ 1.0 x 109/L * Platelets ≥ 100 x 109/L * Creatinine clearance ≥ 30 mL/min * Total bilirubin ≤ 2.0 x the upper limit normal * AST & ALT ≤ 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 (≥ 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 5 years | Recurrence data documented |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | Death data documented |
Countries
Australia, China, India, Indonesia, Malaysia, New Zealand, Saudi Arabia, Singapore, South Korea, Sri Lanka
Outcome results
None listed