COLDFIRE-III Trial Comparing Irreversible Electroporation and Stereotactic Body Radiotherapy for Treating Perivascular and Peribiliary Colorectal Liver Metastases

What this Trial Is About

Researchers are evaluating two non-thermal treatment methods, irreversible electroporation IRE and stereotactic body radiotherapy SBRT, for patients with perivascular or peribiliary colorectal liver metastases CRLM that cannot be removed by surgery or treated with thermal ablation. This phase IIbIII randomized clinical trial aims to compare how well these treatments control tumors locally at 2 years. The study also looks at overall survival, safety, pain, quality of life, and treatment costs. Participants will be randomly assigned to receive either IRE or SBRT. IRE is a minimally invasive procedure that uses electrical pulses to destroy tumor cells near important blood vessels and bile ducts while sparing surrounding tissue. SBRT is a precise form of radiation therapy that delivers a high dose to tumors with less damage to nearby healthy tissue. The trial includes 78 patients with 1 to 3 liver metastases sized 0 to 5 cm, and treatment is guided by CT or MRI imaging. An expert panel determines which tumors are suitable for each procedure. During the study, patients will undergo regular assessments including imaging scans to monitor tumor control, survival, and side effects for up to 5 years. Pain levels and quality of life will be measured with questionnaires for up to 1 year. The trial collects data on safety, tumor progression, and cost-effectiveness. Participants are followed closely to evaluate the impact of each treatment over time, with local tumor control at 2 years as the main outcome.

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