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

Phase 2

• Conditions: Colorectal liver metastases. Metastases in the liver of colon or rectal cancer.; 10019815; 10019818

• Registration Number: NL-OMON56964
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

- 1-3 CRLM F-18-FDG PET avid and visible on ceCT, size <=5 cm and not eligible
for resection or thermal ablation due to location close to a vessel or bile duct
- No or limited extrahepatic disease (1 extrahepatic lesion is allowed, with
some exclusions mentioned in the 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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is local control at 2 years from randomization (per patient<br /><br>analysis). </p><br>

Secondary Outcome Measures

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