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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:
Collaborator:
University Hospital, Ghent
Information provided by:
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT00199173
First received: September 13, 2005
Last updated: February 23, 2011
Last verified: February 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Institut Jules Bordet
ClinicalTrials.gov Identifier: NCT00199173     History of Changes
Other Study ID Numbers: Sir-Spheres1
Study First Received: September 13, 2005
Last Updated: February 23, 2011
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

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
Liver Neoplasms
Neoplasms, Second Primary
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 19, 2013