Comparing Hepatic Intra-arterial Injection of Yttrium-90 Microspheres Versus Fluorouracil (5FU) in Colorectal Cancer Metastatic to the Liver Only
Phase 3
Completed
- Conditions
- Colorectal NeoplasmSecondary Malignant Neoplasm of Liver
- Registration Number
- NCT00199173
- Lead Sponsor
- Jules Bordet Institute
- Brief Summary
This is a Phase III trial comparing hepatic intra-arterial injection of Yttrium-90 microspheres (selective internal radiation \[SIR\] spheres) versus infusional intravenous (IV) 5FU in colorectal cancer metastatic to the liver only and refractory to standard IV chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Histologically proven colorectal adenocarcinoma, metastatic to the liver only.
- Failure of prior chemotherapy for advanced colorectal cancer.
- Adequate laboratory values of hematologic, renal and liver function
- World Health Organization (WHO) performance status (PS) <= 2
- Written consent
Exclusion Criteria
- Pregnant or lactating patients
- Other tumor type than adenocarcinoma (leiomyosarcoma; lymphoma).
- Patients with cirrhosis or other chronic liver disease
- Thrombosis of the hepatic main artery of the portal vein
- Lung shunting > 20% as determined by nuclear medicine breakthrough scan
- Patients with serum bilirubin > 1.0 x upper limit of normal (ULN) or with AST and/or ALT and/or alkaline phosphatase > 5 x ULN
- Patients with concurrent or within 4 week period administration of any other experimental drugs.
- Other serious illness or medical conditions.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Jules Bordet Institute
🇧🇪Brussels, Belgium