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

NCT ID: NCT00199173

Last Updated: 2011-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2010-01-31

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.

Conditions

Colorectal Neoplasm; Secondary Malignant Neoplasm of Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

SIR Spheres intra-arterial hepatic

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: collaborator

Jules Bordet Institute

OTHER

Sponsor Role: lead

Principal Investigators

Alain Hendlisz, MD

Role: PRINCIPAL_INVESTIGATOR

Jules Bordet Institute

Locations

Jules Bordet Institute

Brussels, , Belgium

Countries

Belgium

Other Identifiers

Sir-Spheres1

Identifier Type: -

Identifier Source: org_study_id