Aspirin in Colorectal Cancer Liver Metastases (ASAC)
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|ClinicalTrials.gov Identifier: NCT03326791|
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : January 11, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Liver Metastases Colorectal Cancer Liver Metastases||Drug: Acetylsalicylic acid Drug: Placebo Oral Tablet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Multi-centre, double-blinded, randomized, placebo-controlled clinical intervention trial.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Eligible patients will be allocated in a 1:1 ratio using a computer randomization procedure stratified by centre. The randomization will be blocked within each stratum.|
|Official Title:||Acetylsalicylic Acid as Secondary Prevention in Colorectal Cancer|
|Actual Study Start Date :||December 15, 2017|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2023|
Experimental: Intervention group
Acetylsalicylic acid 160 mg once daily until recurrent disease or a total period of 3 years.
Drug: Acetylsalicylic acid
Trombyl 160 mg once daily
Placebo Comparator: Control group
Placebo Oral Tablet once daily until recurrent disease or a total period of 3 years.
Drug: Placebo Oral Tablet
Placebo one tablet daily
- Disease Free Survival (DFS) after three years treatment [ Time Frame: 3 years ]DFS three years after initiation of treatment with ASA or Placebo after resection of liver metastases.
- Time to recurrence (TTR) of disease after randomization [ Time Frame: 3 years ]Time to recurrence of liver metastases three years after start of treatment.
- Overall survival (OS) three years after treatment start [ Time Frame: 3 years ]OS at three years after initiation of treatment with ASA or Placebo
- Health-related Quality of Life with 36-item Short Form Health Survey (SF-36) [ Time Frame: 3 years ]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.
- Health-related Quality of Life with EuroQoL 5 Dimensions (EQ-5D) [ Time Frame: 3 years ]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).
- ASA in CRC and Cost-Effectiveness Analyses I [ Time Frame: 3 years ]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.
- ASA in CRC and Cost-Effectiveness Analyses II [ Time Frame: 3 years ]Cost-effectiveness measured from a health care perspective by assessing the use of Health care provider in primary and specialized medicine.
- ASA in CRC and Cost-Effectiveness Analyses III [ Time Frame: 3 years ]Cost-effectiveness measured from a societal perspective by assessing records in Statistics Norway (SSB).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326791
|Contact: Anja Kokvoll, Nursefirstname.lastname@example.org|
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|Aarhus University Hospital||Recruiting|
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|Odense University Hospital||Recruiting|
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|Haukeland University Hospital||Recruiting|
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|Oslo University Hospital||Recruiting|
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|Stavanger University Hospital||Recruiting|
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|University Hospital of North-Norway||Recruiting|
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|Skåne University Hospital Lund||Recruiting|
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|Uppsala University Hospital||Recruiting|
|Contact: Bengt Isaksson, MD PhD +46736994477|
|Principal Investigator:||Bjørn A Bjørnbeth, MD PhD||Oslo University Hospital|
|Principal Investigator:||Kjetil Taskèn, MD PhD||University of Oslo|
|Principal Investigator:||Sheraz Yaqub, MD PhD||Oslo University Hospital|