Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial.
Acetylsalicylic acid
Aspirin
Colorectal cancer
Liver metastases
Secondary prevention
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
20 Sep 2021
20 Sep 2021
Historique:
received:
15
12
2020
accepted:
31
08
2021
entrez:
21
9
2021
pubmed:
22
9
2021
medline:
23
9
2021
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.gov NCT03326791 . Registered on 31 October 2017.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov NCT03326791 . Registered on 31 October 2017.
Identifiants
pubmed: 34544470
doi: 10.1186/s13063-021-05587-w
pii: 10.1186/s13063-021-05587-w
pmc: PMC8451095
doi:
Substances chimiques
Aspirin
R16CO5Y76E
Banques de données
ClinicalTrials.gov
['NCT03326791']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
642Subventions
Organisme : Kreftforeningen
ID : 182788
Organisme : Norges Forskningsråd
ID : 235340
Organisme : Helse Sør-Øst RHF
ID : 2016201
Investigateurs
Kristoffer W Brudvik
(KW)
Åsmund A Fretland
(ÅA)
Arild Horn
(A)
Dyre Kleive
(D)
Knut J Labori
(KJ)
Kristoffer Lassen
(K)
Bård I Røsok
(BI)
Jon A Søreide
(JA)
Tore Tholfsen
(T)
Olaug Villanger
(O)
Anne Waage
(A)
Informations de copyright
© 2021. The Author(s).
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