Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers (ASCOLT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by National Cancer Centre, Singapore
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
John Chia Whay Kuang, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier:
NCT00565708
First received: November 29, 2007
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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)

Condition Intervention Phase
Colorectal Cancer
Other: placebo
Drug: Acetylsalicylic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Centre, Singapore:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: December 2008
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acetylsalicylic acid
200mg OD for 3 years
Drug: Acetylsalicylic acid
Adjuvant Therapy
Other Name: Aspirin
Placebo Comparator: Placebo
200mg OD for 3 years
Other: placebo
Placebo Comparator

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

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.
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565708

Contacts
Contact: John Chia 65-96536990 nmocwk@nccs.com.sg

  Show 42 Study Locations
Sponsors and Collaborators
National Cancer Centre, Singapore
University of Oxford
Investigators
Study Chair: John Chia, MBBS, MRCP National Cancer Centre, Singapore
Study Chair: Raghib Ali, MBBS, MRCP University of Oxford
Study Chair: Toh Han Chong, MD, MBBS, MRCP National Cancer Centre, Singapore
  More Information

Additional Information:
No publications provided by National Cancer Centre, Singapore

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Chia Whay Kuang, Senior Consultant, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT00565708     History of Changes
Other Study ID Numbers: CDR0000577892, SINGAPORE-ICR-02, SINGAPORE-ASCOLT, SINGAPORE-07-32-LGI
Study First Received: November 29, 2007
Last Updated: August 13, 2014
Health Authority: Singapore: Health Sciences Authority
Malaysia: Ministry of Health
Malaysia: National Medical Research Register
India: Drugs Controller General of India
Indonesia: Ethics Committee
Korea: Food and Drug Administration
Taiwan: Institutional Review Board
China: Ethics Committee
Hong Kong: Department of Health
Saudi Arabia: Ministry of Health
Sri Lanka: Ministry of Healthcare & Nutrition
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
New Zealand: Institutional Review Board

Keywords provided by National Cancer Centre, Singapore:
stage II colon cancer
stage III colon cancer
stage II rectal cancer
stage III rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014