Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases

Phase 3

Terminated

• Conditions: Colorectal Carcinoma; Liver Metastases

• Registration Number: NCT01233544
• Lead Sponsor: University of Aarhus

Brief Summary

This randomized clinical phase III trial is testing the efficacy of radiofrequency ablation (RFA) and stereotactic body radiotherapy (SBRT) in the treatment of colorectal carcinoma liver metastases.

Primary end point is local progression free survival.

Detailed Description

Patients with 1-4 inoperable colorectal liver metastases, no more 4 cm in diameter are randomized to either RFA or SBRT. Primary end point i local progression free survival. Chemotherapy is allowed before and after study treatment.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Adenocarcinoma of the colon or rectum
• Liver metastases
• Inoperable (technical or medical)
• 1-4 metastases
• Maximum 40 mm in diameter
• Suitable for both therapies, RFA and SBRT

Exclusion Criteria

• Uncontrolled extrahepatic disease and uncontrolled primary cancer
• Liver cirrhosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Local progression-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
Survival	3 years
Progression (local or distant)	3 years
Toxicity	3 years
Quality of life	3 years

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark

Karolinska Institute, Huddinge; 🇸🇪 Stockholm, Sweden