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The Capital Region of Denmark - a part of Copenhagen University Hospital
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Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial

Research output: Contribution to journalJournal articleResearchpeer-review

  • 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.

Original languageEnglish
Article number642
JournalTrials
Volume22
Issue number1
Pages (from-to)642
ISSN1745-6215
DOIs
Publication statusPublished - 20 Sep 2021

Bibliographical note

© 2021. The Author(s).

    Research areas

  • Aspirin/adverse effects, Colorectal Neoplasms/prevention & control, Double-Blind Method, Humans, Liver Neoplasms/drug therapy, Multicenter Studies as Topic, Neoplasm Recurrence, Local/prevention & control, Quality of Life, Randomized Controlled Trials as Topic, Secondary Prevention

ID: 68604580