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NCT01233544 Clinical Trial

Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases

Liver Metastases Clinical Trial

— RAS01  

Official title:
The International Liver Tumor Group RAS-trial Radiofrequency Ablation Versus Stereotactic Body Radiation Therapy for Colorectal Liver Metastases: A Randomized Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01233544
Other study ID # RAS 01
Secondary ID
Status Terminated
Phase Phase 3
First received November 2, 2010
Last updated May 11, 2016
Start date September 2010
Est. completion date December 2014

Study information
Verified date May 2015
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Terminated
Enrollment 300
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• SBRT or RFA
Patients are allocated to one of the two arms in a 1:1 randomization

Locations
Country Name City State
Denmark Aarhus University Hospital Aarhus C
Sweden Karolinska Institute, Huddinge Stockholm

Sponsors (2)
Lead Sponsor Collaborator
University of Aarhus Danish Center for Interventional Research in Radiation Oncology (CIRRO)

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Local progression-free survival 3 years No
Secondary Toxicity 3 years Yes
Secondary Survival 3 years No
Secondary Progression (local or distant) 3 years No
Secondary Quality of life 3 years No
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