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

Primary Purpose

Colorectal Carcinoma, Liver Metastases

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

SBRT or RFA

About this trial

This is an interventional treatment trial for Colorectal Carcinoma focused on measuring Colorectal carcinoma, Liver metastases, Stereotactic body radiation therapy, Radiofrequency ablation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aarhus University Hospital
Karolinska Institute, Huddinge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stereotactic body radiation therapy

Radiofrequency ablation

Arm Description

Colorectal liver metastases treated by SBRT

Colorectal liver metastases treated by RFA

Outcomes

Primary Outcome Measures

Local progression-free survival

Secondary Outcome Measures

Toxicity

Survival

Progression (local or distant)

Quality of life

Full Information

NCT ID

NCT01233544

First Posted

November 2, 2010

Last Updated

May 11, 2016

Sponsor

University of Aarhus

Collaborators

Danish Center for Interventional Research in Radiation Oncology (CIRRO)

1. Study Identification

Unique Protocol Identification Number

NCT01233544

Brief Title

Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases

Acronym

RAS01

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Terminated

Why Stopped

Insufficient recruitment

Study Start Date

September 2010 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

Collaborators

Danish Center for Interventional Research in Radiation Oncology (CIRRO)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Carcinoma, Liver Metastases

Keywords

Colorectal carcinoma, Liver metastases, Stereotactic body radiation therapy, Radiofrequency ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stereotactic body radiation therapy

Arm Type

Experimental

Arm Description

Colorectal liver metastases treated by SBRT

Arm Title

Radiofrequency ablation

Arm Type

Active Comparator

Arm Description

Colorectal liver metastases treated by RFA

Intervention Type

Procedure

Intervention Name(s)

SBRT or RFA

Other Intervention Name(s)

Stereotactic body radiation therapy, Radiofrequency ablation

Intervention Description

Patients are allocated to one of the two arms in a 1:1 randomization

Primary Outcome Measure Information:

Title

Local progression-free survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Toxicity

Time Frame

3 years

Title

Survival

Time Frame

3 years

Title

Progression (local or distant)

Time Frame

3 years

Title

Quality of life

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Morten Høyer, MD PhD

Organizational Affiliation

Aarhus University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aarhus University Hospital

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Karolinska Institute, Huddinge

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

12. IPD Sharing Statement

Links:

URL

http://www.cirro.dk

Description

Centre for Interventional Research in Radiation Oncology

Learn more about this trial

Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases

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