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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University of Aarhus
Sponsor:
Collaborator:
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01233544
First received: November 2, 2010
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Colorectal Carcinoma
Liver Metastases
Procedure: SBRT or RFA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The International Liver Tumor Group RAS-trial Radiofrequency Ablation Versus Stereotactic Body Radiation Therapy for Colorectal Liver Metastases: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Local progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Progression (local or distant) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Stereotactic body radiation therapy
  • Radiofrequency ablation
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:
  • Stereotactic body radiation therapy
  • Radiofrequency ablation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233544

Contacts
Contact: Morten Høyer, MD PhD +45 89492529 hoyer@aarhus.rm.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus C, Denmark, 8000
Contact: Morten Høyer, MD PhD    +45 89492529    hoyer@aarhus.rm.dk   
Principal Investigator: Morten Høyer, MD PhD         
Sweden
Karolinska Institute, Huddinge Recruiting
Stockholm, Sweden, 141 86
Contact: Peter Wersell, MD PhD       peter.wersall@karolinska.se   
Contact: Marika Sventelius, Research nurse    +46 8 616 45 59    marika.sventelius@karolinska.se   
Principal Investigator: Peter Wersell, MD PhD         
Sponsors and Collaborators
University of Aarhus
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Investigators
Principal Investigator: Morten Høyer, MD PhD Aarhus University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01233544     History of Changes
Other Study ID Numbers: RAS 01
Study First Received: November 2, 2010
Last Updated: June 18, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University of Aarhus:
Colorectal carcinoma
Liver metastases
Stereotactic body radiation therapy
Radiofrequency ablation

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases

ClinicalTrials.gov processed this record on August 21, 2014