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

Primary Purpose

Colorectal Neoplasm, Secondary Malignant Neoplasm of Liver

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
SIR Spheres intra-arterial hepatic
Sponsored by
Jules Bordet Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasm focused on measuring colorectal cancer, liver metastasis, intraarterial hepatic injection, yttrium loaded microspheres, colorectal neoplasm metastatic to the liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Jules Bordet Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
February 23, 2011
Sponsor
Jules Bordet Institute
Collaborators
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT00199173
Brief Title
Comparing Hepatic Intra-arterial Injection of Yttrium-90 Microspheres Versus Fluorouracil (5FU) in Colorectal Cancer Metastatic to the Liver Only
Official Title
Comparison Hepatic Intra-arterial Injection of Yttrium-90 Versus 5FU in Colorectal Cancer Metastatic to the Liver Only
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jules Bordet Institute
Collaborators
University Hospital, Ghent

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasm, Secondary Malignant Neoplasm of Liver
Keywords
colorectal cancer, liver metastasis, intraarterial hepatic injection, yttrium loaded microspheres, colorectal neoplasm metastatic to the liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
SIR Spheres intra-arterial hepatic

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Hendlisz, MD
Organizational Affiliation
Jules Bordet Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jules Bordet Institute
City
Brussels
ZIP/Postal Code
1000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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