ACETYLSALICYLIC ACID AS SECONDARY PREVENTION IN COLORECTAL CANCER (ASAC TRIAL)
- Conditions
- iver metastasis from colorectal cancer.MedDRA version: 20.0 Level: LLT Classification code 10010029 Term: Colorectal cancer NOS System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003601-15-DK
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 800
All subjects undergoing liver resection for CRCLM as a part of a curative
intent may be included in the study if
• They meet one of the following criteria:
o First time CRCLM (synchronous or metachronous)
o Recurrence of CRCLM (not previously included in this trial)
• Histologically verified free resection margins (R0 resection or R1 (<1mm margin + chemotherapy))
• Must be ambulatory with a performance status ECOG 0-2
• Must be at least 18 years of age
• Signed informed consent and expected cooperation of the patients for
the treatment and follow up must be obtained and documented
according to ICH GCP, and national/local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500
Concomitant use of ASA or other anticoagulants or platelet inhibitors such as warfarin or klopidogrel
• Ongoing regular use of corticosteroids, NSAIDs
• Inherited or acquired coagulopathy (hemophilia)
• Severe heart failure (classified as NYHA class >III) or kidney failure
• CRCLM treated with radiofrequency or microwave ablation technique
• Pregnancy or breastfeeding (negative pregnancy test will be required
when indicated)
• Childbearing potential without proper contraceptive measures such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to avoid pregnancy for the entire study period
• Liver cirrhosis with a Child-Pugh score >B7
• Contraindication listed on the Summary of Product Characteristics (SmPC) of Trombyl:
• Hypersensitivity/allergies to ASA
• Previous severe gastrointestinal haemorrage/peptic ulcer due to ASA/NSAID
• Active peptic ulcer
• Hemophilia
• Need to use medications contraindicated according to SmPC of
Trombyl from Medicines Agency
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method