Yttrium Y 90 Glass Microspheres in Treating Patients With Unresectable Hepatocellular Carcinoma (NCT01176604) | Clinical Trial Compass
CompletedNot Applicable
Yttrium Y 90 Glass Microspheres in Treating Patients With Unresectable Hepatocellular Carcinoma
United States299 participantsStarted 2010-08-04
Plain-language summary
This trial studies how well yttrium Y 90 glass microspheres work in treating patients with hepatocellular carcinoma that cannot be removed by surgery. Radioactive drugs, such as yttrium Y 90 glass microspheres, may carry radiation directly to cancer cells and not harm normal cells.
Who can participate
SexALL
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Inclusion Criteria:
* Diagnosis of intrahepatic HCC. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alphafetoprotein (AFP) and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing HCC
* Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2
* Life expectancy \>= 3 months
* \> 4 weeks since prior radiation, surgery or chemotherapy
* Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
Exclusion Criteria:
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times upper normal limit (UNL) (within 15 days of treatment demonstrating liver dysfunction)
* Serum bilirubin \> 2.0 mg/dl (unless segmental infusion is planned) (within 15 days of treatment demonstrating liver dysfunction)
* Any contraindications to angiography and hepatic artery catheterization such as:
* History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
* Bleeding diathesis, not correctable by usual forms of therapy
* Severe peripheral vascular disease that would preclude catheterization
* Evidence of poteā¦
What they're measuring
1
Oversight to treatment with yttrium Y 90 glass microspheres