Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases (RAS01)

May 11, 2016 updated by: University of Aarhus

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Aarhus University Hospital
  • Sweden
      • Stockholm, Sweden, 141 86
        • Karolinska Institute, Huddinge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stereotactic body radiation therapy
Colorectal liver metastases treated by SBRT
Procedure: SBRT or RFA
Patients are allocated to one of the two arms in a 1:1 randomization
Other Names:
  • Radiofrequency ablation
  • Stereotactic body radiation therapy
Active Comparator: Radiofrequency ablation
Colorectal liver metastases treated by RFA
Procedure: SBRT or RFA
Patients are allocated to one of the two arms in a 1:1 randomization
Other Names:
  • Radiofrequency ablation
  • Stereotactic body radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Local progression-free survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 3 years
3 years
Survival
Time Frame: 3 years
3 years
Toxicity
Time Frame: 3 years
3 years
Progression (local or distant)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Danish Center for Interventional Research in Radiation Oncology (CIRRO)

Investigators

  • Principal Investigator: Morten Høyer, MD PhD, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 2, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (Estimate)

November 3, 2010

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAS 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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