• Medientyp: E-Artikel
  • Titel: Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial
  • Beteiligte: Yaqub, Sheraz; Bjørnbeth, Bjørn Atle; Angelsen, Jon-Helge; Fristrup, Claus Wilki; Grønbech, Jon Erik; Hemmingsson, Oskar; Isaksson, Bengt; Juel, Ingebjørg Soterud; Larsen, Peter Nørgaard; Lindell, Gert; Mortensen, Frank Viborg; Mortensen, Kim Erlend; Rizell, Magnus; Sandström, Per; Sandvik, Oddvar Mathias; Sparrelid, Ernesto; Taflin, Helena; Taskén, Kjetil; Brudvik, Kristoffer W.; Fretland, Åsmund A.; Horn, Arild; Kleive, Dyre; Labori, Knut J.; Lassen, Kristoffer; [...]
  • Erschienen: Springer Science and Business Media LLC, 2021
  • Erschienen in: Trials
  • Sprache: Englisch
  • DOI: 10.1186/s13063-021-05587-w
  • ISSN: 1745-6215
  • Schlagwörter: Pharmacology (medical) ; Medicine (miscellaneous)
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  • Beschreibung: <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration</jats:title> <jats:p>ClinicalTrials.gov NCT03326791. Registered on 31 October 2017.</jats:p> </jats:sec>
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