Perivascular and peribiliary colorectal liver metastases (0-5 cm): irreversible electroporation versus stereotactic body radiotherapy.

Perivascular and peribiliary colorectal liver metastases (0-5 cm): irreversible electroporation versus stereotactic body radiotherapy. - COLDFIRE-III

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56964

Enrollment

Registered

2024-08-20

Start date

2024-10-09

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal liver metastases. Metastases in the liver of colon or rectal cancer.

Interventions

Patients will be randomized into one of two arms, arm A (IRE) and arm B (SBRT). The expert panel, consisting of at least two interventional radiologists, two radiation oncologists and two hepatobili

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 1-3 CRLM F-18-FDG PET avid and visible on ceCT, size

Exclusion criteria

Exclusion criteria: • Radical treatment unfeasible or unsafe (e.g. insufficient FLR); • >10 CRLM; • Positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis;

Design outcomes

Primary

Measure	Time frame
Primary endpoint is local control at 2 years from randomization (per patient analysis).	—

Secondary

Measure	Time frame
Secondary endpoints are local tumor progression free survival, OS, distant progression-free survival (DPFS), time to progression (TTP), procedural morbidity/toxicity and mortality, assessment of pain and quality of life (QoL) and cost-effectiveness ratio (ICER).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)