Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases
Phase 3
Terminated
- Conditions
- Colorectal CarcinomaLiver Metastases
- Interventions
- Procedure: SBRT or RFA
- 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.
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
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Exclusion Criteria
- Uncontrolled extrahepatic disease and uncontrolled primary cancer
- Liver cirrhosis
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stereotactic body radiation therapy SBRT or RFA Colorectal liver metastases treated by SBRT Radiofrequency ablation SBRT or RFA Colorectal liver metastases treated by RFA
- 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