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UNKNOWNPHASE3

Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers

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

NCT00565708•National Cancer Centre, Singapore

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

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.
+7 more criteria

Locations (67)

Bankstown-Lidcombe Hospital Bankstown Cancer Centre

Bankstown, New South Wales, Australia

Macarthur Cancer Therapy Centre

Campbelltown, New South Wales, Australia

Chris O'Brien Lifehouse, Clinical Research Centre

Camperdown, New South Wales, Australia

Coffs Harbour Health Campus North Coast Cancer Institute

Coffs Harbour, New South Wales, Australia

Central Coast Cancer Centre Gosford Hospital

Gosford, New South Wales, Australia

Newcastle private Hospital

New Lambton Heights, New South Wales, Australia

Orange Health Service

Orange, New South Wales, Australia

Port Macquarie Base Hospital North Coast Cancer Institute

Port Macquarie, New South Wales, Australia

Northern Cancer Institute, St Leonards

St Leonards, New South Wales, Australia

St Vincent's Hospital

Sydney, New South Wales, Australia

Key Dates

Start Date

December 1, 2008

Primary Completion Date

June 1, 2024

Completion Date

June 1, 2024

Last Updated

February 2, 2024

Enrollment

1,587

ACTUAL participants

Conditions

Colorectal Cancer

Interventions

placebo

OTHER

Acetylsalicylic acid

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors