Radioembolization for Colorectal Liver Metastases after Ablation: a Prospective study

Phase 2

Completed

• Conditions: 'Colorectal liver metastases' and 'liver cancer disseminated from the colon'; 10019815; 10017998

• Registration Number: NL-OMON41502
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint of the study is the local liver recurrence rate after 12<br /><br>months of follow-up (the local liver recurrence)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the occurrence of any treatment related adverse event<br /><br>within one month after the Y-90 radioembolization procedure, intrahepatic<br /><br>recurrences and quality of life. </p><br>