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Aspirin in Colorectal Cancer Liver Metastases

NCT03326791 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 466

Last updated 2025-07-31

No results posted yet for this study

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

Interventions

DRUG

Acetylsalicylic acid

Trombyl 160 mg once daily

DRUG

Placebo Oral Tablet

Placebo one tablet daily

Sponsors & Collaborators

  • Norwegian Cancer Society

    collaborator OTHER

  • The Research Council of Norway

    collaborator OTHER

  • Klinbeforsk

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Kjetil Taskèn, MD PhD · University of Oslo

  • Sheraz Yaqub, MD PhD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2022-02-01
Completion
2026-06-30

Countries

  • Denmark
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03326791 on ClinicalTrials.gov