Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases

NCT ID: NCT01233544

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Carcinoma Liver Metastases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stereotactic body radiation therapy

Colorectal liver metastases treated by SBRT

Group Type EXPERIMENTAL

SBRT or RFA

Intervention Type PROCEDURE

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

Radiofrequency ablation

Colorectal liver metastases treated by RFA

Group Type ACTIVE_COMPARATOR

SBRT or RFA

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SBRT or RFA

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Stereotactic body radiation therapy Radiofrequency ablation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Danish Center for Interventional Research in Radiation Oncology (CIRRO)

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Morten Høyer, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aarhus University Hospital

Aarhus C, , Denmark

Site Status

Karolinska Institute, Huddinge

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark Sweden

Related Links

Access external resources that provide additional context or updates about the study.

http://www.cirro.dk

Centre for Interventional Research in Radiation Oncology

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RAS 01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Radiofrequency Ablation of Lung Tumors
NCT00180856 COMPLETED PHASE2