Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial) : study protocol for a multicentre randomized placebo-controlled trial
(2021) In Trials 22(1).- 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... (More)
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.
(Less)
- author
- author collaboration
- publishing date
- 2021-12-01
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Acetylsalicylic acid, Aspirin, Colorectal cancer, Liver metastases, Secondary prevention
- in
- Trials
- volume
- 22
- issue
- 1
- article number
- 642
- publisher
- BioMed Central (BMC)
- external identifiers
-
- pmid:34544470
- scopus:85115645160
- ISSN
- 1745-6215
- DOI
- 10.1186/s13063-021-05587-w
- language
- English
- LU publication?
- no
- additional info
- Publisher Copyright: © 2021, The Author(s).
- id
- 60595bad-ea55-4dd2-9423-3ca63e183b8b
- date added to LUP
- 2021-11-19 11:52:56
- date last changed
- 2024-04-06 13:15:25
@article{60595bad-ea55-4dd2-9423-3ca63e183b8b,
abstract = {{<p>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.</p>}},
author = {{Yaqub, Sheraz and Bjørnbeth, Bjørn Atle and Angelsen, Jon Helge and Fristrup, Claus Wilki and Grønbech, Jon Erik and Hemmingsson, Oskar and Isaksson, Bengt and Juel, Ingebjørg Soterud and Larsen, Peter Nørgaard and Lindell, Gert and Mortensen, Frank Viborg and Mortensen, Kim Erlend and Rizell, Magnus and Sandström, Per and Sandvik, Oddvar Mathias and Sparrelid, Ernesto and Taflin, Helena and Taskén, Kjetil and Brudvik, Kristoffer W. and Fretland, Åsmund A. and Horn, Arild and Kleive, Dyre and Labori, Knut J. and Lassen, Kristoffer and Røsok, Bård I. and Søreide, Jon A. and Tholfsen, Tore and Villanger, Olaug and Waage, Anne}},
issn = {{1745-6215}},
keywords = {{Acetylsalicylic acid; Aspirin; Colorectal cancer; Liver metastases; Secondary prevention}},
language = {{eng}},
month = {{12}},
number = {{1}},
publisher = {{BioMed Central (BMC)}},
series = {{Trials}},
title = {{Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial) : study protocol for a multicentre randomized placebo-controlled trial}},
url = {{http://dx.doi.org/10.1186/s13063-021-05587-w}},
doi = {{10.1186/s13063-021-05587-w}},
volume = {{22}},
year = {{2021}},
}