Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers (ASCOLT)
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| ClinicalTrials.gov Identifier: NCT00565708 |
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Recruitment Status :
Active, not recruiting
First Posted : November 30, 2007
Last Update Posted : September 13, 2021
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Sponsor:
National Cancer Centre, Singapore
Collaborators:
University of Oxford
Australasian Gastro-Intestinal Trials Group
INDOX Cancer Research Network
Information provided by (Responsible Party):
John Chia Whay Kuang, National Cancer Centre, Singapore
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Brief 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
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer | Other: placebo Drug: Acetylsalicylic acid | Phase 3 |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1587 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, 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 |
| Study Start Date : | December 2008 |
| Estimated Primary Completion Date : | December 2025 |
| Estimated Study Completion Date : | June 2026 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: acetylsalicylic acid
200mg OD for 3 years
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Drug: Acetylsalicylic acid
Adjuvant Therapy
Other Name: Aspirin |
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Placebo Comparator: Placebo
200mg OD for 3 years
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Other: placebo
Placebo Comparator |
Primary Outcome Measures :
- Disease-free survival [ Time Frame: 5 years ]
Secondary Outcome Measures :
- Overall survival [ Time Frame: 5 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565708
Locations
Show 68 study locations
Sponsors and Collaborators
National Cancer Centre, Singapore
University of Oxford
Australasian Gastro-Intestinal Trials Group
INDOX Cancer Research Network
Investigators
| Study Chair: | John Chia, MBBS, MRCP | National Cancer Centre, Singapore | |
| Study Chair: | Raghib Ali, MBBS, MRCP | University of Oxford | |
| Study Chair: | Han Chong Toh, MD, MBBS, MRCP | National Cancer Centre, Singapore | |
| Study Chair: | Eva Segelov, MBBS,FRACP,PhD | St Vincent's Hospital |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
| Other Study ID Numbers: |
CDR0000577892 SINGAPORE-ICR-02 ( Other Identifier: SCRI ) SINGAPORE-ASCOLT ( Other Identifier: SCRI ) |
| First Posted: | November 30, 2007 Key Record Dates |
| Last Update Posted: | September 13, 2021 |
| Last Verified: | September 2021 |
Keywords provided by John Chia Whay Kuang, National Cancer Centre, Singapore:
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stage II colon cancer stage III colon cancer stage II rectal cancer stage III rectal cancer |
Additional relevant MeSH terms:
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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 Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |