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

Free University of Brussels (ULB)

Status and phase

Completed

Phase 3

Conditions

Colorectal Neoplasm

Secondary Malignant Neoplasm of Liver

Treatments

Device: SIR Spheres intra-arterial hepatic

Study type

Interventional

Funder types

Other

Identifiers

NCT00199173

Sir-Spheres1

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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.