Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases
Conditions
Colorectal Carcinoma - Liver Metastases
Conditions: official terms
Colorectal Neoplasms - Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
Colorectal carcinoma, Liver metastases, Stereotactic body radiation therapy, Radiofrequency ablation
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: SBRT or RFA
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Aarhus University Hospital
Aarhus C, Denmark
Status: Recruiting
Contact: Morten Høyer, MD PhD - +45 89492529 - hoyer@aarhus.rm.dk
Karolinska Institute, Huddinge
Stockholm, Sweden
Status: Recruiting
Contact: Peter Wersell, MD PhD - peter.wersall@karolinska.se
Start Date
September 2010
Completion Date
December 2016
Sponsors
University of Aarhus
Source
University of Aarhus
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page