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RECRUITING
NCT06185556
PHASE2/PHASE3

COLDFIRE-III Trial: Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases

Sponsor: Amsterdam UMC, location VUmc

View on ClinicalTrials.gov

Summary

The primary objective of this phase IIb/III, prospective, randomized clinical trial is to compare the efficacy of irreversible electroporation (IRE) with stereotactic body radiotherapy (SBRT) in patients with perivascular or peribiliary colorectal liver metastases (CRLM), that are not amenable for surgical resection or thermal ablation. Efficacy is assessed in terms of local control at 2 years.

Official title: COLDFIRE-III Trial: Perivascular and Peribiliary Colorectal Liver Metastases (0-5cm): Irreversible Electroporation Versus Stereotactic Body Radiotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2024-08-20

Completion Date

2031-09-01

Last Updated

2024-08-23

Healthy Volunteers

No

Interventions

PROCEDURE

Irreversible electroporation

Percutaneous (CT-guided) irreversible electroporation of 1-3 perivascular and peribiliary colorectal liver metastasis.

RADIATION

Stereotactic body radiotherapy

Stereotactic body radiotherapy (CT- or MRI-guided) of 1-3 perivascular and peribiliary colorectal liver metastases.

Locations (1)

Amsterdam UMC - location VUmc

Amsterdam, North Holland, Netherlands