Colorectal Cancer Liver MetastasesPhase 2/3ASACNCT03326791
Aspirin in Colorectal Cancer Liver Metastases
A Phase 2/3 study testing Acetylsalicylic acid in people with Colorectal Cancer Liver Metastases and Colorectal Cancer, run by Oslo University Hospital at 14 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Liver Metastases, Colorectal Cancer, Liver Metastases
- What is being tested?
- Acetylsalicylic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 466 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 15 Dec 2017to 1 Jun 2026
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Sweden6 sites
Sahlgranska University Hospital
Gothenburg, Gothenburg
Linköping University Hospital
Linköping, Linköping
Skåne University Hospital Lund
Lund, Lund
Karolinska University Hospital
Stockholm, Stockholm County
University Hospital of Umeå
Umeå
Uppsala University Hospital
Uppsala, Uppsala County
Norway5 sites
Haukeland University Hospital
Bergen, Bergen
Oslo University Hospital
Oslo, Oslo
Stavanger University Hospital
Stavanger, Stavanger
University Hospital of North-Norway
Tromsø, Tromsø
St Olavs Hospital
Trondheim, Trondheim
Denmark3 sites
Aarhus University Hospital
Aarhus, Aarhus
Rigshospitalet, Copenhagen
Copenhagen, Copenhagen
Odense University Hospital
Odense
About this study
Official title: Acetylsalicylic Acid as Secondary Prevention in Colorectal Cancer
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.
- Being tested
- Acetylsalicylic acid, Placebo Oral Tablet
- Keywords
- Acetylsalicylic acid, Aspirin, Trombyl, Secondary prevention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acidDrug
Also called Trombyl, Aspirin
Trombyl 160 mg once daily
Placebo Oral TabletDrug
Placebo one tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Acetylsalicylic acid 160 mg once daily until recurrent disease or a total period of 3 years. Receives: Drug: Acetylsalicylic acid |
| Control group | Placebo comparator | Placebo Oral Tablet once daily until recurrent disease or a total period of 3 years. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS) after three years treatment
DFS three years after initiation of treatment with ASA or Placebo after resection of liver metastases.
Measured: 3 years
Secondary outcomes (7)
Time to recurrence (TTR) of disease after randomization
Time to recurrence of liver metastases three years after start of treatment.
Measured: 3 years
Overall survival (OS) three years after treatment start
OS at three years after initiation of treatment with ASA or Placebo
Measured: 3 years
Health-related Quality of Life with 36-item Short Form Health Survey (SF-36)
SF-36 has been proven useful in monitoring population health, estimating the burdens of different diseases, monitoring outcome in clinical practice, and evaluating medical treatment effects. Health-related Quality of Life (HR-QoL) will be assessed with SF-36.
Measured: 3 years
Health-related Quality of Life with EuroQoL 5 Dimensions (EQ-5D)
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. This will be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions will be presented as a health profile. Health-related Quality of Life (HR-QoL) will be assessed with EuroQoL 5 Dimensions (EQ-5D).
Measured: 3 years
ASA in CRC and Cost-Effectiveness Analyses I
Changes in HR-QoL will be used in calculation of the quality-adjusted life-year (QALY), a key outcome used in economic evaluations to compare treatments.
Measured: 3 years
ASA in CRC and Cost-Effectiveness Analyses II
Cost-effectiveness measured from a health care perspective by assessing the use of Health care provider in primary and specialized medicine.
Measured: 3 years
ASA in CRC and Cost-Effectiveness Analyses III
Cost-effectiveness measured from a societal perspective by assessing records in Statistics Norway (SSB).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start15 Dec 2017
- Primary completion1 Feb 2022
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-centre, double-blinded, randomized, placebo-controlled clinical intervention trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Cancer Society, The Research Council of Norway, Klinbeforsk
- Responsible party
- Principal investigator, Sheraz Yaqub, Oslo University Hospital
- Investigators
- Kjetil Taskèn, MD PhD, Principal investigator, University of OsloSheraz Yaqub, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326791
- Sponsor's protocol ID
- 2014/2217
- Acronym
- ASAC
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2017
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yaqub S, Valberg M, Bjornbeth BA, Angelsen JH, Brudvik KW, Eilertsen IA, Fristedt R, Fristrup CW, Gilg S, Hemmingsson O, Isaksson B, Juel IS, Knudsen AR, Larsen PN, Mortensen KE, Olsen IC, Sandstrom P, Sandvik OM, Sparrelid E, Taflin H, Lothe RA, Tasken K; ASAC Study Group. Aspirin after curative-intent treatment of colorectal cancer liver metastases (ASAC): a multicentre, phase 3, randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2026 Sep 23:S2468-1253(26)00260-8. doi: 10.1016/S2468-1253(26)00260-8. Online ahead of print.
PubMed 42777749Yaqub 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.
PubMed 34544470