Comparing Hepatic Intra-arterial Injection of Yttrium-90 Microspheres Versus Fluorouracil (5FU) in Colorectal Cancer Metastatic to the Liver Only

Sponsor

Jules Bordet Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00199173

Collaborator

University Hospital, Ghent (Other)

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasm Secondary Malignant Neoplasm of Liver	Device: SIR Spheres intra-arterial hepatic	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison Hepatic Intra-arterial Injection of Yttrium-90 Versus 5FU in Colorectal Cancer Metastatic to the Liver Only

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.