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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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
Are there results?
None posted in the registry

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
Show all 13Show fewer
  • 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

Other trials in Sweden

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

Other trials in Norway

Denmark3 sites

  • Aarhus University Hospital

    Aarhus, Aarhus

  • Rigshospitalet, Copenhagen

    Copenhagen, Copenhagen

  • Odense University Hospital

    Odense

Other trials in Denmark

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 groups in NCT03326791
Study groupRoleWhat they receive
Intervention groupExperimentalAcetylsalicylic acid 160 mg once daily until recurrent disease or a total period of 3 years.
Receives: Drug: Acetylsalicylic acid
Control groupPlacebo comparatorPlacebo 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.

  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.

    Measured: 3 years

Secondary outcomes (7)

  1. Time to recurrence (TTR) of disease after randomization

    Time to recurrence of liver metastases three years after start of treatment.

    Measured: 3 years

  2. Overall survival (OS) three years after treatment start

    OS at three years after initiation of treatment with ASA or Placebo

    Measured: 3 years

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted31 Oct 2017
  2. Study start15 Dec 2017
  3. Primary completion1 Feb 2022
  4. Study completion1 Jun 2026

Resources

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)
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 42777749

  • 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.

    PubMed 34544470

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Sweden, Norway, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (DFS) after three years treatment (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03326791, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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