. 2021 Sep 20;22(1):642.

doi: 10.1186/s13063-021-05587-w.

Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial

Sheraz Yaqub^{1

2}, Bjørn Atle Bjørnbeth³, Jon-Helge Angelsen^{4

5}, Claus Wilki Fristrup⁶, Jon Erik Grønbech^{7

8}, Oskar Hemmingsson⁹, Bengt Isaksson¹⁰, Ingebjørg Soterud Juel⁷, Peter Nørgaard Larsen¹¹, Gert Lindell¹², Frank Viborg Mortensen¹³, Kim Erlend Mortensen¹⁴, Magnus Rizell¹⁵, Per Sandström^{16

17}, Oddvar Mathias Sandvik¹⁸, Ernesto Sparrelid¹⁹, Helena Taflin²⁰, Kjetil Taskén²¹; ASAC study group

Collaborators, Affiliations

Collaborators

ASAC study group:
Kristoffer W Brudvik, Åsmund A Fretland, Arild Horn, Dyre Kleive, Knut J Labori, Kristoffer Lassen, Bård I Røsok, Jon A Søreide, Tore Tholfsen, Olaug Villanger, Anne Waage

Affiliations

¹ Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway. shya@ous-hf.no.
² Institute of Clinical Medicine, University of Oslo, Oslo, Norway. shya@ous-hf.no.
³ Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway.
⁴ Department of Acute and Digestive Surgery, Haukeland University Hospital, Bergen, Norway.
⁵ Departments of Clinical Medicine, University of Bergen, Bergen, Norway.
⁶ Department of Surgery, Odense University Hospital, Odense C, Denmark.
⁷ Department of Gastrointestinal Surgery, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.
⁸ Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.
⁹ Department of Surgical and Perioperative Sciences, Umeå University, Umea, Sweden.
¹⁰ Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
¹¹ Department of Gastrointestinal Surgery, Rigshospitalet, Copenhagen, Denmark.
¹² Department of Surgery, Skåne University Hospital, Lund, Sweden.
¹³ Department of Surgery, Aarhus University Hospital, Aarhus N, Denmark.
¹⁴ Department of Gastrointestinal Surgery, University Hospital of North, Tromsø, Norway.
¹⁵ Department of Transplantation, Institute of Clinical Sciences, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.
¹⁶ Department of Surgery, County Council of Östergötland, Linköping, Sweden.
¹⁷ Department of Biomedical and Clinical Sciences, Division of Surgery, Orthopedics and Oncology, Linköping, Sweden.
¹⁸ Department of Gastrointestinal Surgery, Stavanger University Hospital, Stavanger, Norway.
¹⁹ Division of Surgery, Department of Clinical Science, Intervention, and Technology (CLINTEC), Center for Digestive Diseases, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden.
²⁰ Department of Surgery, Institute of Clinical Sciences, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.
²¹ Institute for Cancer Research, Oslo University Hospital, and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

PMID: 34544470
PMCID: PMC8451095
DOI: 10.1186/s13063-021-05587-w

Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial

Sheraz Yaqub et al. Trials. 2021.

. 2021 Sep 20;22(1):642.

doi: 10.1186/s13063-021-05587-w.

Authors

Collaborators

ASAC study group:
Kristoffer W Brudvik, Åsmund A Fretland, Arild Horn, Dyre Kleive, Knut J Labori, Kristoffer Lassen, Bård I Røsok, Jon A Søreide, Tore Tholfsen, Olaug Villanger, Anne Waage

Affiliations

¹ Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway. shya@ous-hf.no.
² Institute of Clinical Medicine, University of Oslo, Oslo, Norway. shya@ous-hf.no.
³ Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway.
⁴ Department of Acute and Digestive Surgery, Haukeland University Hospital, Bergen, Norway.
⁵ Departments of Clinical Medicine, University of Bergen, Bergen, Norway.
⁶ Department of Surgery, Odense University Hospital, Odense C, Denmark.
⁷ Department of Gastrointestinal Surgery, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.
⁸ Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.
⁹ Department of Surgical and Perioperative Sciences, Umeå University, Umea, Sweden.
¹⁰ Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
¹¹ Department of Gastrointestinal Surgery, Rigshospitalet, Copenhagen, Denmark.
¹² Department of Surgery, Skåne University Hospital, Lund, Sweden.
¹³ Department of Surgery, Aarhus University Hospital, Aarhus N, Denmark.
¹⁴ Department of Gastrointestinal Surgery, University Hospital of North, Tromsø, Norway.
¹⁵ Department of Transplantation, Institute of Clinical Sciences, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.
¹⁶ Department of Surgery, County Council of Östergötland, Linköping, Sweden.
¹⁷ Department of Biomedical and Clinical Sciences, Division of Surgery, Orthopedics and Oncology, Linköping, Sweden.
¹⁸ Department of Gastrointestinal Surgery, Stavanger University Hospital, Stavanger, Norway.
¹⁹ Division of Surgery, Department of Clinical Science, Intervention, and Technology (CLINTEC), Center for Digestive Diseases, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden.
²⁰ Department of Surgery, Institute of Clinical Sciences, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.
²¹ Institute for Cancer Research, Oslo University Hospital, and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

PMID: 34544470
PMCID: PMC8451095
DOI: 10.1186/s13063-021-05587-w

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.

Keywords: Acetylsalicylic acid; Aspirin; Colorectal cancer; Liver metastases; Secondary prevention.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

**Fig. 2**
Schematic overview of timeline for patients included in the ASAC trial

See this image and copyright information in PMC

References

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Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial

Collaborators

Affiliations

Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical