Status:
COMPLETED
Comparing Hepatic Intra-arterial Injection of Yttrium-90 Microspheres Versus Fluorouracil (5FU) in Colorectal Cancer Metastatic to the Liver Only
Lead Sponsor:
Jules Bordet Institute
Collaborating Sponsors:
University Hospital, Ghent
Conditions:
Colorectal Neoplasm
Secondary Malignant Neoplasm of Liver
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 canc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
January 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00199173
End Date
January 1 2010
Last Update
February 24 2011
Active Locations (1)
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1
Jules Bordet Institute
Brussels, Belgium, 1000