The ASAC trial is a Scandinavian, multi-center, double-blinded, randomized, placebo-controlled study to determine whether adjuvant treatment with low-dose acetylsalicylic acid (ASA) can improve disease free survival in patients treated with resection for colorectal cancer liver metastases (CRCLM). Several studies have shown beneficial effect of ASA on primary prevention of CRC and the investigators group and others have shown a potential association of ASA also taken after the diagnosis on CRC survival in registry-based studies (secondary prevention). 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 till disease recurrence. The patients will be treated and followed up according to standard of care and the National Guidelines. The ASAC trial will be the first clinical interventional trial to assess the beneficial role of ASA in recurrence of CRC liver metastases and survival. ASA is an inexpensive, well tolerated, and easily accessible drug that will be highly potential as adjuvant drug in secondary prevention of CRC liver metastases if the study shows a beneficial effect. This trial will also investigate the effect of ASA as adjuvant treatment on Health-related Quality of Life and the cost-effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
466
Trombyl 160 mg once daily
Placebo one tablet daily
Aarhus University Hospital
Aarhus, Aarhus, Denmark
Rigshospitalet, Copenhagen
Copenhagen, Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Haukeland University Hospital
Bergen, Bergen, Norway
Oslo University Hospital
Oslo, Oslo, Norway
Stavanger University Hospital
Stavanger, Stavanger, Norway
University Hospital of North-Norway
Tromsø, Tromsø, Norway
St Olavs Hospital
Trondheim, Trondheim, Norway
Sahlgranska University Hospital
Gothenburg, Gothenburg, Sweden
Linköping University Hospital
Linköping, Linköping, Sweden
...and 4 more locations
Disease Free Survival (DFS) after three years treatment
DFS three years after initiation of treatment with ASA or Placebo after resection of liver metastases.
Time frame: 3 years
Time to recurrence (TTR) of disease after randomization
Time to recurrence of liver metastases three years after start of treatment.
Time frame: 3 years
Overall survival (OS) three years after treatment start
OS at three years after initiation of treatment with ASA or Placebo
Time frame: 3 years
Health-related Quality of Life with 36-item Short Form Health Survey (SF-36)
SF-36 has been proven useful in monitoring population health, estimating the burdens of different diseases, monitoring outcome in clinical practice, and evaluating medical treatment effects. Health-related Quality of Life (HR-QoL) will be assessed with SF-36.
Time frame: 3 years
Health-related Quality of Life with EuroQoL 5 Dimensions (EQ-5D)
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. This will be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions will be presented as a health profile. Health-related Quality of Life (HR-QoL) will be assessed with EuroQoL 5 Dimensions (EQ-5D).
Time frame: 3 years
ASA in CRC and Cost-Effectiveness Analyses I
Changes in HR-QoL will be used in calculation of the quality-adjusted life-year (QALY), a key outcome used in economic evaluations to compare treatments.
Time frame: 3 years
ASA in CRC and Cost-Effectiveness Analyses II
Cost-effectiveness measured from a health care perspective by assessing the use of Health care provider in primary and specialized medicine.
Time frame: 3 years
ASA in CRC and Cost-Effectiveness Analyses III
Cost-effectiveness measured from a societal perspective by assessing records in Statistics Norway (SSB).
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.