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

University of Aarhus

Status and phase: Terminated; Phase 3

Conditions: Colorectal Carcinoma; Liver Metastases

Treatments: Procedure: SBRT or RFA

Study type: Interventional

Funder types: Other

Identifiers

NCT01233544

RAS 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Stereotactic body radiation therapy

Experimental group

Description:

Colorectal liver metastases treated by SBRT

Treatment:

Procedure: SBRT or RFA

Radiofrequency ablation

Active Comparator group

Description:

Colorectal liver metastases treated by RFA

Treatment:

Procedure: SBRT or RFA