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Completed

NCT Number: NCT00199173

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

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.

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Key information

Conditions

Colorectal Neoplasm Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Secondary Malignant Neoplasm of Liver

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jules Bordet Institute

Brussels, 1000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SIR Spheres intra-arterial hepatic

Device

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Collaborators

  • University Hospital, Ghent

Registry information

Official study title

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

Important dates

Primary completion
2010
Study completion
2010
First posted
Sep 20, 2005
Registry last updated
Feb 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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