NL-OMON41502
Completed
Phase 2
Radioembolization for Colorectal Liver Metastases after Ablation: a Prospective study - The RELAPSE study
niversitair Medisch Centrum Utrecht0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- 'Colorectal liver metastases' and 'liver cancer disseminated from the colon'
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who have signed written informed consent
- •2\. Patients undergoing open, laparoscopic or percutaneous ablation therapy
- •3\. Age \* 18 years
- •4\. ECOG performance status of 0\-2
- •5\. Subjects with at least one and a maximum of five measurable lesion according to the RECIST criteria (\>5\.0 cm in axial plane) on pre\-operative imaging
- •6\. Normal renal and liver function tests at baseline
Exclusion Criteria
- •1\. Irresectable extrahepatic metastases
- •2\. Ablation procedure combined with liver resection
- •3\. Pregnant or breast\-feeding patients
- •4\. Any form of chemotherapy within 2 months prior to the Y\-90 radioembolization
- •5\. Exclusion criteria of radioembolization:
- •\- Compromised main portal vein
- •\- Uncorrectable extrahepatic shunting to the gastrointestinal tract
- •\- Unacceptable shunting to the lungs
Outcomes
Primary Outcomes
Not specified
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