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Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial
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....
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8451095/ https://www.ncbi.nlm.nih.gov/pubmed/34544470 http://dx.doi.org/10.1186/s13063-021-05587-w |
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author | Yaqub, Sheraz Bjørnbeth, Bjørn Atle Angelsen, Jon-Helge Fristrup, Claus Wilki Grønbech, Jon Erik Hemmingsson, Oskar Isaksson, Bengt Juel, Ingebjørg Soterud Larsen, Peter Nørgaard Lindell, Gert Mortensen, Frank Viborg Mortensen, Kim Erlend Rizell, Magnus Sandström, Per Sandvik, Oddvar Mathias Sparrelid, Ernesto Taflin, Helena Taskén, Kjetil |
author_facet | Yaqub, Sheraz Bjørnbeth, Bjørn Atle Angelsen, Jon-Helge Fristrup, Claus Wilki Grønbech, Jon Erik Hemmingsson, Oskar Isaksson, Bengt Juel, Ingebjørg Soterud Larsen, Peter Nørgaard Lindell, Gert Mortensen, Frank Viborg Mortensen, Kim Erlend Rizell, Magnus Sandström, Per Sandvik, Oddvar Mathias Sparrelid, Ernesto Taflin, Helena Taskén, Kjetil |
author_sort | Yaqub, Sheraz |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8451095 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-84510952021-09-20 Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial Yaqub, Sheraz Bjørnbeth, Bjørn Atle Angelsen, Jon-Helge Fristrup, Claus Wilki Grønbech, Jon Erik Hemmingsson, Oskar Isaksson, Bengt Juel, Ingebjørg Soterud Larsen, Peter Nørgaard Lindell, Gert Mortensen, Frank Viborg Mortensen, Kim Erlend Rizell, Magnus Sandström, Per Sandvik, Oddvar Mathias Sparrelid, Ernesto Taflin, Helena Taskén, Kjetil Trials Study Protocol 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. BioMed Central 2021-09-20 /pmc/articles/PMC8451095/ /pubmed/34544470 http://dx.doi.org/10.1186/s13063-021-05587-w Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Yaqub, Sheraz Bjørnbeth, Bjørn Atle Angelsen, Jon-Helge Fristrup, Claus Wilki Grønbech, Jon Erik Hemmingsson, Oskar Isaksson, Bengt Juel, Ingebjørg Soterud Larsen, Peter Nørgaard Lindell, Gert Mortensen, Frank Viborg Mortensen, Kim Erlend Rizell, Magnus Sandström, Per Sandvik, Oddvar Mathias Sparrelid, Ernesto Taflin, Helena Taskén, Kjetil Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial |
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 | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8451095/ https://www.ncbi.nlm.nih.gov/pubmed/34544470 http://dx.doi.org/10.1186/s13063-021-05587-w |
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