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Spots Global Cancer Trial Database for Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

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Trial Identification

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

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

Study ID: NCT01899261

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Albert Einstein College of Medicine, Bronx, New York, United States

Contact Details

Name: Nitin Ohri

Affiliation: Albert Einstein College of Medicine

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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