Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial
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,
The ASAC study group
Affiliations
Sheraz Yaqub
Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital
Bjørn Atle Bjørnbeth
Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital
Jon-Helge Angelsen
Department of Acute and Digestive Surgery, Haukeland University Hospital
Claus Wilki Fristrup
Department of Surgery, Odense University Hospital
Jon Erik Grønbech
Department of Gastrointestinal Surgery, St. Olav’s Hospital, Trondheim University Hospital
Oskar Hemmingsson
Department of Surgical and Perioperative Sciences, Umeå University
Bengt Isaksson
Department of Surgical Sciences, Uppsala University
Ingebjørg Soterud Juel
Department of Gastrointestinal Surgery, St. Olav’s Hospital, Trondheim University Hospital
Peter Nørgaard Larsen
Department of Gastrointestinal Surgery, Rigshospitalet
Gert Lindell
Department of Surgery, Skåne University Hospital
Frank Viborg Mortensen
Department of Surgery, Aarhus University Hospital
Kim Erlend Mortensen
Department of Gastrointestinal Surgery, University Hospital of North
Magnus Rizell
Department of Transplantation, Institute of Clinical Sciences, University of Gothenburg, Sahlgrenska University Hospital
Per Sandström
Department of Surgery, County Council of Östergötland
Oddvar Mathias Sandvik
Department of Gastrointestinal Surgery, Stavanger University Hospital
Ernesto Sparrelid
Division of Surgery, Department of Clinical Science, Intervention, and Technology (CLINTEC), Center for Digestive Diseases, Karolinska University Hospital, Karolinska Institute
Helena Taflin
Department of Surgery, Institute of Clinical Sciences, University of Gothenburg, Sahlgrenska University Hospital
Kjetil Taskén
Institute for Cancer Research, Oslo University Hospital, and Institute of Clinical Medicine, University of Oslo
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.
