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Trial record 1 of 1 for:    NCT00199173
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Comparing Hepatic Intra-arterial Injection of Yttrium-90 Microspheres Versus Fluorouracil (5FU) in Colorectal Cancer Metastatic to the Liver Only

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00199173
First Posted: September 20, 2005
Last Update Posted: February 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital, Ghent
Information provided by:
Jules Bordet Institute
  Purpose
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 Intervention Phase
Colorectal Neoplasm Secondary Malignant Neoplasm of Liver Device: SIR Spheres intra-arterial hepatic Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jules Bordet Institute:

Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199173


Locations
Belgium
Jules Bordet Institute
Brussels, Belgium, 1000
Sponsors and Collaborators
Jules Bordet Institute
University Hospital, Ghent
Investigators
Principal Investigator: Alain Hendlisz, MD Jules Bordet Institute
  More Information

Responsible Party: Institut Jules Bordet
ClinicalTrials.gov Identifier: NCT00199173     History of Changes
Other Study ID Numbers: Sir-Spheres1
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: February 24, 2011
Last Verified: February 2011

Keywords provided by Jules Bordet Institute:
colorectal cancer
liver metastasis
intraarterial hepatic injection
yttrium loaded microspheres
colorectal neoplasm metastatic to the liver

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases