Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial
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 th...
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| Format: | Article |
| Language: | English |
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BMC
2021-09-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05587-w |
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| author | 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 |
| author_facet | 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 |
| author_sort | Sheraz Yaqub |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-17T19:19:39Z |
| format | Article |
| id | doaj.art-dca8c8b2998b47948bef26011e98df45 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-17T19:19:39Z |
| publishDate | 2021-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-dca8c8b2998b47948bef26011e98df452022-12-21T21:35:36ZengBMCTrials1745-62152021-09-0122111310.1186/s13063-021-05587-wAspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trialSheraz Yaqub0Bjørn Atle Bjørnbeth1Jon-Helge Angelsen2Claus Wilki Fristrup3Jon Erik Grønbech4Oskar Hemmingsson5Bengt Isaksson6Ingebjørg Soterud Juel7Peter Nørgaard Larsen8Gert Lindell9Frank Viborg Mortensen10Kim Erlend Mortensen11Magnus Rizell12Per Sandström13Oddvar Mathias Sandvik14Ernesto Sparrelid15Helena Taflin16Kjetil Taskén17The ASAC study groupDepartment of Hepato-Pancreato-Biliary Surgery, Oslo University HospitalDepartment of Hepato-Pancreato-Biliary Surgery, Oslo University HospitalDepartment of Acute and Digestive Surgery, Haukeland University HospitalDepartment of Surgery, Odense University HospitalDepartment of Gastrointestinal Surgery, St. Olav’s Hospital, Trondheim University HospitalDepartment of Surgical and Perioperative Sciences, Umeå UniversityDepartment of Surgical Sciences, Uppsala UniversityDepartment of Gastrointestinal Surgery, St. Olav’s Hospital, Trondheim University HospitalDepartment of Gastrointestinal Surgery, RigshospitaletDepartment of Surgery, Skåne University HospitalDepartment of Surgery, Aarhus University HospitalDepartment of Gastrointestinal Surgery, University Hospital of NorthDepartment of Transplantation, Institute of Clinical Sciences, University of Gothenburg, Sahlgrenska University HospitalDepartment of Surgery, County Council of ÖstergötlandDepartment of Gastrointestinal Surgery, Stavanger University HospitalDivision of Surgery, Department of Clinical Science, Intervention, and Technology (CLINTEC), Center for Digestive Diseases, Karolinska University Hospital, Karolinska InstituteDepartment of Surgery, Institute of Clinical Sciences, University of Gothenburg, Sahlgrenska University HospitalInstitute for Cancer Research, Oslo University Hospital, and Institute of Clinical Medicine, University of OsloAbstract 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.https://doi.org/10.1186/s13063-021-05587-wColorectal cancerLiver metastasesAspirinAcetylsalicylic acidSecondary prevention |
| spellingShingle | 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 Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial Trials Colorectal cancer Liver metastases Aspirin Acetylsalicylic acid Secondary prevention |
| title | Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial |
| title_full | Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial |
| title_fullStr | Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial |
| title_full_unstemmed | Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial |
| title_short | Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial |
| title_sort | aspirin as secondary prevention in colorectal cancer liver metastasis asac trial study protocol for a multicentre randomized placebo controlled trial |
| topic | Colorectal cancer Liver metastases Aspirin Acetylsalicylic acid Secondary prevention |
| url | https://doi.org/10.1186/s13063-021-05587-w |
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