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

Colorectal Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199173
• Other study ID #: Sir-Spheres1
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: February 23, 2011
• Est. completion date: January 2010

Study information

• Verified date: February 2011
• Source: Jules Bordet Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasm
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasms
• Neoplasms, Second Primary
• Secondary Malignant Neoplasm of Liver

Intervention

Device:
• SIR Spheres intra-arterial hepatic

Locations

Country	Name	City	State
Belgium	Jules Bordet Institute	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Jules Bordet Institute	University Hospital, Ghent

Country where clinical trial is conducted

Belgium,