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Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial
Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway.
Department of Acute and Digestive Surgery, Haukeland University Hospital, Bergen, Norway; Departments of Clinical Medicine, University of Bergen, Bergen, Norway.
Department of Surgery, Odense University Hospital, Odense C, Denmark.
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2021 (English)In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 642Article in journal (Refereed) Published
Abstract [en]

Background: Colorectal cancer is one the most common cancers in the western world with increasing incidence. Approximately 50% of the patients develop liver metastases. Resection of liver metastases is the treatment of choice although almost half of the resected patients get recurrence in the liver.

Methods: The ASAC trial is a Scandinavian, multicentre, double-blinded, randomized, placebo-controlled study to determine whether adjuvant treatment with low-dose aspirin (acetylsalicylic acid (ASA)) can improve disease-free survival in patients treated for colorectal cancer liver metastases (CRCLM). 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 until disease recurrence. The patients will be recruited at all major hepatobiliary surgical units in Norway, Sweden and Denmark and have follow-up according to standard of care and the National Guidelines.

Discussion: The ASAC trial will be the first clinical interventional trial to assess the potential beneficial role of ASA in recurrence of CRCLM and survival. ASA is an inexpensive, well-tolerated and easily accessible drug that will be highly potential as adjuvant drug in secondary prevention of CRCLM if the study shows a beneficial effect. We will also determine the effect of ASA as adjuvant treatment on Health-Related Quality of Life and the cost-effectiveness. 

Place, publisher, year, edition, pages
BioMed Central (BMC), 2021. Vol. 22, no 1, article id 642
Keywords [en]
Acetylsalicylic acid, Aspirin, Colorectal cancer, Liver metastases, Secondary prevention
National Category
Cancer and Oncology
Identifiers
URN: urn:nbn:se:umu:diva-188164DOI: 10.1186/s13063-021-05587-wISI: 000700269700002Scopus ID: 2-s2.0-85115645160OAI: oai:DiVA.org:umu-188164DiVA, id: diva2:1600975
Available from: 2021-10-06 Created: 2021-10-06 Last updated: 2024-04-08Bibliographically approved

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Hemmingsson, Oskar

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