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Aspirin in Colorectal Cancer Liver Metastases
Sponsor: Oslo University Hospital
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.
Official title: Acetylsalicylic Acid as Secondary Prevention in Colorectal Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
466
Start Date
2017-12-15
Completion Date
2026-06
Last Updated
2025-07-31
Healthy Volunteers
No
Interventions
Acetylsalicylic acid
Trombyl 160 mg once daily
Placebo Oral Tablet
Placebo one tablet daily
Locations (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