Status:
ACTIVE_NOT_RECRUITING
Aspirin in Colorectal Cancer Liver Metastases
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Norwegian Cancer Society
The Research Council of Norway
Conditions:
Colorectal Cancer Liver Metastases
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The ASAC trial is a Scandinavian, multi-center, double-blinded, randomized, placebo-controlled study to determine whether adjuvant treatment with low-dose acetylsalicylic acid (ASA) can improve diseas...
Eligibility Criteria
Inclusion
- First time CRCLM (synchronous or metachronous).
- Recurrence of CRCLM (not previously included in this trial).
- In synchronous CRCLM and "Liver first" approach, the primary tumor must be resected within 6 weeks after the liver
- Macroscopic (surgical) free resection margins (R0 or R1 resection).
- Must be ambulatory with a performance status Eastern Cooperative Oncology Group (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 International Conference on Harmonization - Good Clinical Practice (ICH GCP), and national/local regulations.
Exclusion
- Concomitant use of ASA or other anticoagulants or platelet inhibitors such as warfarin or clopidogrel.
- Ongoing regular use of corticosteroids or NSAIDs.
- Inherited or acquired coagulopathy (haemophilia).
- Blood platelets (thrombocytes) \< 100 x 10\^9/L.
- Severe heart failure (classified as New York Heart Association (NYHA) class \>III)
- Severe kidney failure \>Stage 3b
- CRCLM previously treated with radiofrequency or microwave ablation technique
- Pregnancy or breastfeeding. For women in childbearing age there will be pregnancy test at monthly intervals (urine human chorionic gonadotropin (HCG) pregnancy tests (for home testing) will be given to the patients for monthly tests and the patient will self-report the results at each control). Furthermore, highly effective contraceptives will be required.
- 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 to avoid pregnancy for the entire study period.
- Liver cirrhosis with a Child-Pugh score \>B7.
- Alcoholism.
- Contraindication listed on the Summary of Product Characteristics (SmPC) of Trombyl: Hypersensitivity/allergies to ASA, Thrombocytopenia, Previous severe gastrointestinal haemorrhage/peptic ulcer due to ASA/NSAID, Active peptic ulcer, Haemophilia, Liver cirrhosis, Severe congestive heart failure.
- Need to use concomitant medications contraindicated according to SmPC of Trombyl.
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT03326791
Start Date
December 15 2017
End Date
June 1 2026
Last Update
July 31 2025
Active Locations (14)
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1
Aarhus University Hospital
Aarhus, Aarhus, Denmark
2
Rigshospitalet, Copenhagen
Copenhagen, Copenhagen, Denmark
3
Odense University Hospital
Odense, Denmark
4
Haukeland University Hospital
Bergen, Bergen, Norway