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Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers

NCT00565708 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1587

Last updated 2024-02-02

No results posted yet for this study

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)

Conditions

Interventions

OTHER

placebo

Placebo Comparator

DRUG

Acetylsalicylic acid

Adjuvant Therapy

Sponsors & Collaborators

  • Australasian Gastro-Intestinal Trials Group

    collaborator NETWORK

  • INDOX Cancer Research Network

    collaborator OTHER

  • University of Sydney

    collaborator OTHER

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • John Chia, MBBS, MRCP · National Cancer Centre, Singapore

  • Raghib Ali, MBBS,MRCP · NYU

  • Han Chong Toh, MD,MBBS,MRCP · National Cancer Centre, Singapore

  • Eva Segelov, MBBS,PhD · Monash University, University of Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Australia
  • China
  • India
  • Indonesia
  • Malaysia
  • New Zealand
  • Saudi Arabia
  • Singapore
  • South Korea
  • Sri Lanka

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00565708 on ClinicalTrials.gov