Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Advanced Adult Hepatocellular Carcinoma Clinical Trial

Official title: A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma

Status Completed

Clinical Trial Summary

This pilot clinical trial studies stereotactic body radiation therapy in treating patients with liver cancer that cannot be removed by surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate feasibility and safety of stereotactic body radiation therapy (SBRT) of the liver for treatment of hepatocellular carcinoma (HCC).

SECONDARY OBJECTIVES:

I. To evaluate radiographic local response, local control and time to local progression (TTLP) of treated lesions in HCC patients after liver SBRT.

II. To evaluate overall survival (OS) and cancer specific survival (CSS) in HCC patients treated with liver SBRT.

III. To evaluate explanted irradiated liver tissue (for patients who proceed to liver transplantation) to determine extent of residual tumor and extent of radiation effects within and around the irradiated field.

OUTLINE:

Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months for up to 2 years. ;

Related Conditions & MeSH terms

• Adult Hepatocellular Carcinoma
• Advanced Adult Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular
• Liver Neoplasms
• Localized Non-Resectable Adult Liver Carcinoma
• Recurrent Adult Liver Carcinoma

• NCT number: NCT01899261
• Study type: Interventional
• Source: Albert Einstein College of Medicine
• Status: Completed
• Phase: N/A
• Start date: October 7, 2010
• Completion date: May 2019