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Intervention protocol 06

Radiofrequency ablation versus stereotactic body radiation therepy for colorectal liver metastases: A randomized trial

Objectives A number of retrospective studies have shown that 25-40% of patients with colorectal liver metastases may be long term survivors after surgical resection of the metastases. However, only 10-20% of patients with liver metastases are operable based on technical criteria and there is a demand for alternative methods for ablation of liver metastases. Radiofrequency ablation (RFA) is the most frequently used method for ablation of metastases. RFA of liver metastases results in high probability of local control, promising survival and low complication rate. Stereotactic body radiotherapy (SBRT) may as well be used in ablation of liver metastases. By SBRT the tumour is treated with a few high radiation doses precisely delivered with a small margin to the target. Phase II studies have demonstrated high efficacy, and limited toxicity of SBRT. The aim of the study is to compare the two treatments in an international multicenter study.
Study outline (intervention) A total number of 200 patients is planned to be included from 2008. Patients will be randomized between RFA and SBRT. Primary Endpoint: local control. Secondary endpoints: toxicity, survival, distant progression and quality of life. Furthermore the study will allow the investigators to explore the treatment parameters for patients treated with RFA and the dose-volume relationship for patients treated with SBRT and to correlate these to toxicity grades.
Expected impact The study is aimed to identify the most efficient treatment for patients with unresectable liver metastases.
Linkages with work packages WP 2, 5, 6, 8, 9. From WP2: FAZA PET/CT. From WP05: 4DCT dose planning and respiratory guided treatment. From WP06 CBCT for further improvement of precision in delivery. From WP09 analyzing relationship between treatment related parameters and toxicity.