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


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasm, Secondary Malignant Neoplasm of Liver

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Alain Hendlisz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jules Bordet Institute

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

Sir-Spheres1

NCT ID:

NCT00199173

Start Date:

Completion Date:

January 2010

Related Keywords:

  • Colorectal Neoplasm
  • Secondary Malignant Neoplasm of Liver
  • colorectal cancer
  • liver metastasis
  • intraarterial hepatic injection
  • yttrium loaded microspheres
  • colorectal neoplasm metastatic to the liver
  • Neoplasms
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Neoplasms, Second Primary

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