Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases

Phase 3TerminatedNCT01233544

University of Aarhus300 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Colorectal Carcinoma Liver Metastases

Interventions

SBRT or RFAPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (2)

Aarhus University Hospital

Aarhus C, Denmark

Karolinska Institute, Huddinge

Stockholm, Sweden

Outcomes

Primary Outcomes

Local progression-free survival

Time frame: 3 years

Secondary Outcomes

Toxicity

Time frame: 3 years

Survival

Time frame: 3 years

Progression (local or distant)

Time frame: 3 years

Quality of life

Time frame: 3 years

Data from ClinicalTrials.gov

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