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

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.

Trial Details

NCT ID
NCT06185556
Phase
PHASE2 / PHASE3
Sponsor
Amsterdam UMC, location VUmc
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Irreversible electroporation
  • Stereotactic body radiotherapy
Locations (sample)
  • Amsterdam, North Holland, Netherlands|52.37403,4.88969

Key Eligibility Criteria

  • Histological documentation of primary colorectal tumor is available;
  • 1-3 CRLM visible on ceCT and/or MRI, size 0-5 cm and not eligible for resection or thermal ablation due to location close to a vessel or bile duct;
  • Additional CRLM are allowed if considered either resectable or ablatable with a maximum of 10 CRLM. In patients with extrahepatic disease, a maximu…
  • No or limited extrahepatic disease (1 extrahepatic lesion is allowed, with some exclusions mentioned in the exclusion criteria);

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Colon Cancer Colorectal Cancer Trials on Trialify →