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Region Hovedstaden - en del af Københavns Universitetshospital
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Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  • Sheraz Yaqub
  • Bjørn Atle Bjørnbeth
  • Jon-Helge Angelsen
  • Claus Wilki Fristrup
  • Jon Erik Grønbech
  • Oskar Hemmingsson
  • Bengt Isaksson
  • Ingebjørg Soterud Juel
  • Peter Nørgaard Larsen
  • Gert Lindell
  • Frank Viborg Mortensen
  • Kim Erlend Mortensen
  • Magnus Rizell
  • Per Sandström
  • Oddvar Mathias Sandvik
  • Ernesto Sparrelid
  • Helena Taflin
  • Kjetil Taskén
  • ASAC study group
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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.

OriginalsprogEngelsk
Artikelnummer642
TidsskriftTrials
Vol/bind22
Udgave nummer1
Sider (fra-til)642
ISSN1745-6215
DOI
StatusUdgivet - 20 sep. 2021

Bibliografisk note

© 2021. The Author(s).

ID: 68604580