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Aspirin in Colorectal Cancer Liver Metastases

Study acronym: ASAC
StatusActive, Not Recruiting
PhasePhase 2/3
Started2017-12-15
View on ClinicalTrials.gov ↗

Amendment history

2025-07-28
Study Status, Contacts/Locations v11
Completion date2025-02→2026-06
Study sitesdetails revised at 12 of 14 sites
2023-12-12
Study Status v10
Re-verified, no change to tracked fields
2022-10-19
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Completion date2026-02→2025-02
Enrollment targetestimated 800→confirmed 466
Study sitesdetails revised at 14 of 14 sites
2022-04-21
Study Status v8
Primary completion dateestimated 2023-10→confirmed 2022-02-01
Completion date2026-10→2026-02
2021-07-02
Study Status, Contacts/Locations v7
Completion date2025-10→2026-10
Show 6 earlier versions
2020-03-05
Study Status, Contacts/Locations v6
Completion date2023-10→2025-10
Study sitescontacts updated at 2 of 14 sites
2019-02-15
Study Status, Study Design v5
PhasePhase 2→Phase 2/3
2019-01-10
Study Status, Eligibility, Contacts/Locations v4
Eligibility criteria+124 characters
[...] ecurrence 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 rese [...] k Heart Association (NYHA) class >III) Severe kidney failure. >Stage 3b CRCLM previously treated with radiofrequency or microwave a [...]
Study sitesdetails revised at 11 of 14 sites
2018-01-19
Study Status, Contacts/Locations v3
Re-verified, no change to tracked fields
2018-01-16
Study Status, Contacts/Locations v2
Start dateestimated 2017-12→confirmed 2017-12-15
Study sitesdetails revised at 2 of 14 sites
2017-12-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Recruiting
Start date2017-11→2017-12
Study sites12→14
2017-10-25
Original filing
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 Details
NCT Number NCT03326791
Lead Sponsor Oslo University Hospital
Collaborators: Norwegian Cancer Society, The Research Council of Norway, Klinbeforsk
Conditions Colorectal Cancer Liver Metastases, Colorectal Cancer, Liver Metastases
Enrollment 466 participants
Start Date 2017-12-15
Primary Completion 2022-02-01 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-07-31