ASCOLT Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers.

Phase 3

Active, not recruiting

• Conditions: Colorectal Cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12614000513617
• Lead Sponsor: Australasian Gastro-Intestinal Trial Group (AGITG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-15
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

Male or female outpatient of at least 18 years of age or at least the 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
- Undergone complete resection of primary tumour
- Completed standard therapy (at least 3 months of chemotherapy with or without radiotherapy)
- Within 120 days of completion of standard therapy (surgery, chemotherapy with or without 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 GroupB-F57
- ANC greater than or equal to 1.0 x 109/L
- Platelets greater than or equal to 100 x 109/L
- Creatinine clearance greater than or equal to 30 mL/min
- Total bilirubin less than or equal to 2.0 x the upper limit
normal
- AST & ALT less than or equal to 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 (greater
than or equal to 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified