Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial
Yaqub, Sheraz; Bjørnbeth, Bjørn Atle; Angelsen, Jon-Helge; Fristrup, Claus W.; Grønbech, Jon Erik; Hemmingsson, Oskar; Isaksson, Bengt; Juel, Ingebjørg Soterud; Larsen, Peter Nørgaard; Lindell, Gert; Mortensen, Frank V.; Mortensen, Kim Erlend; Rizell, Magnus; Sandström, Per; Sandvik, Oddvar Mathias; Sparrelid, Ernesto; Taflin, Helena; Taskén, Kjetil; Brudvik, Kristoffer Watten; Fretland, Åsmund Avdem; Horn, Arild; Kleive, Dyre; Labori, Knut Jørgen; Lassen, Kristoffer; Røsok, Bård Ingvald; Søreide, Jon Arne; Tholfsen, Tore; Villanger, Olaug; Waage, Anne
Journal article, Peer reviewed
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2021Metadata
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Abstract
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. Trial registration: ClinicalTrials.gov NCT03326791. Registered on 31 October 2017.