Aspirin in Colorectal Cancer Liver Metastases
ASAC
Acetylsalicylic Acid as Secondary Prevention in Colorectal Cancer
1 other identifier
interventional
466
3 countries
14
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 disease free survival in patients treated with resection for colorectal cancer liver metastases (CRCLM). Several studies have shown beneficial effect of ASA on primary prevention of CRC and the investigators group and others have shown a potential association of ASA also taken after the diagnosis on CRC survival in registry-based studies (secondary prevention). Up to 800 patients operated for CRCLM will be randomized to Arm#1 ASA 160 mg once daily or Arm#2 Placebo for a period of 3 years or till disease recurrence. The patients will be treated and followed up according to standard of care and the National Guidelines. The ASAC trial will be the first clinical interventional trial to assess the beneficial role of ASA in recurrence of CRC liver metastases and survival. ASA is an inexpensive, well tolerated, and easily accessible drug that will be highly potential as adjuvant drug in secondary prevention of CRC liver metastases if the study shows a beneficial effect. This trial will also investigate the effect of ASA as adjuvant treatment on Health-related Quality of Life and the cost-effectiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2017
Longer than P75 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedStudy Start
First participant enrolled
December 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedJuly 31, 2025
July 1, 2025
4.1 years
October 2, 2017
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease Free Survival (DFS) after three years treatment
DFS three years after initiation of treatment with ASA or Placebo after resection of liver metastases.
3 years
Secondary Outcomes (7)
Time to recurrence (TTR) of disease after randomization
3 years
Overall survival (OS) three years after treatment start
3 years
Health-related Quality of Life with 36-item Short Form Health Survey (SF-36)
3 years
Health-related Quality of Life with EuroQoL 5 Dimensions (EQ-5D)
3 years
ASA in CRC and Cost-Effectiveness Analyses I
3 years
- +2 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALAcetylsalicylic acid 160 mg once daily until recurrent disease or a total period of 3 years.
Control group
PLACEBO COMPARATORPlacebo Oral Tablet once daily until recurrent disease or a total period of 3 years.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- Norwegian Cancer Societycollaborator
- The Research Council of Norwaycollaborator
- Klinbeforskcollaborator
Study Sites (14)
Aarhus University Hospital
Aarhus, Aarhus, Denmark
Rigshospitalet, Copenhagen
Copenhagen, Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Haukeland University Hospital
Bergen, Bergen, Norway
Oslo University Hospital
Oslo, Oslo County, Norway
Stavanger University Hospital
Stavanger, Stavanger, Norway
University Hospital of North-Norway
Tromsø, Tromsø, Norway
St Olavs Hospital
Trondheim, Trondheim, Norway
Sahlgranska University Hospital
Gothenburg, Gothenburg, Sweden
Linköping University Hospital
Linköping, Linköping, Sweden
Skåne University Hospital Lund
Lund, Lund, Sweden
Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Uppsala University Hospital
Uppsala, Uppsala County, Sweden
University Hospital of Umeå
Umeå, Sweden
Related Publications (1)
Yaqub S, Bjornbeth BA, Angelsen JH, Fristrup CW, Gronbech JE, Hemmingsson O, Isaksson B, Juel IS, Larsen PN, Lindell G, Mortensen FV, Mortensen KE, Rizell M, Sandstrom P, Sandvik OM, Sparrelid E, Taflin H, Tasken K; ASAC study group. Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial. Trials. 2021 Sep 20;22(1):642. doi: 10.1186/s13063-021-05587-w.
PMID: 34544470DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kjetil Taskèn, MD PhD
University of Oslo
- PRINCIPAL INVESTIGATOR
Sheraz Yaqub, MD PhD
Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Eligible patients will be allocated in a 1:1 ratio using a computer randomization procedure stratified by centre. The randomization will be blocked within each stratum.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD, Coordinating Investigator
Study Record Dates
First Submitted
October 2, 2017
First Posted
October 31, 2017
Study Start
December 15, 2017
Primary Completion
February 1, 2022
Study Completion (Estimated)
June 1, 2026
Last Updated
July 31, 2025
Record last verified: 2025-07