Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers

Trial number:
NCT00565708
Trial phase:
3
Study type:
Supportive interventions, Observational
Overall status:
Recruiting

Study start date

December, 2008

Scientific title

Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial

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)

Male or female outpatient of ≥ 18 years of age or ≥ country's legal age for adult consentDukes 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

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: Triple, Subject masked: Yes, Caregiver masked: Yes, Investigator masked: Yes,

Conditions

Colorectal Cancer

Other study ID numbers

CDR0000577892; SINGAPORE-ICR-02; SINGAPORE-ASCOLT

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