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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.
University Hospital, Ghent
Information provided by:
Jules Bordet Institute Identifier:
First received: September 13, 2005
Last updated: February 23, 2011
Last verified: February 2011
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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00199173

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

Responsible Party: Institut Jules Bordet Identifier: NCT00199173     History of Changes
Other Study ID Numbers: Sir-Spheres1
Study First Received: September 13, 2005
Last Updated: February 23, 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:
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 processed this record on September 21, 2017