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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Bowel<br/>CancersCancer LocationBowel
Cancers

Systemic therapy | Bowel (colorectum)Colon,Colorectum,Rectum

Trial Overview Read MoreRead more

This phase III trial is investigating asprin for Dukes C and high risk Dukes B colorectal cancers.
 

This trial is treating patients with Dukes C and high risk Dukes B Colorectal Cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has not spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT00565708
  • CDR0000577892, SINGAPORE-ICR-02, SINGAPORE-ASCOLT, SINGAPORE-07-32-LGI, AG0213CR, ICR02

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

Cooperative Group

Australasian Gastro-Intestinal Trials Group (AGITG)

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)

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Ballarat Hospital
Ballarat
Ms Carmel Goss
CarmelG@bhs.org.au
03 5320 4735

Border Medical Oncology
Albury
Ms Nyree Sarakis
Nsarkis@bordermedonc.com.au
02 6064 1493

Barwon Health, University Hospital Geelong
Geelong
Dr Lea-Anne Harrison
leaanne.harrison@barwonhealth.org.au
03 42 15 2758

Goulburn Valley Health
Shepparton
Ms Vicki Clowes
oncologyclinicaltrials@gvhealth.org.au
(03) 5832 3777

Monash Health, Medical Oncology
Clayton
GI Research Study Coordinator
gi.oncresearch@monashhealth.org

Warrnambool Hospital
Warrnambool
Sandra Robinson
sjrobinson@swh.net.au
03 5562 9056

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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