NCT03326791

Aspirin in Colorectal Cancer Liver Metastases

Acetylsalicylic Acid as Secondary Prevention in Colorectal Cancer

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 466 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Colorectal Cancer Liver Metastases
• Colorectal Cancer
• Liver Metastases

Interventions

Type	Name	Description
DRUG	Acetylsalicylic acid	Trombyl 160 mg once daily
DRUG	Placebo Oral Tablet	Placebo one tablet daily

Timeline

• Start date: 2017-12-15
• Primary completion: 2022-02-01
• Completion: 2026-06-01
• First posted: 2017-10-31
• Last updated: 2025-07-31

Locations

14 sites across 3 countries: Denmark, Norway, Sweden