Trials / Completed
CompletedNCT01899261
Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Albert Einstein College of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Adult Hepatocellular Carcinoma
- Advanced Adult Hepatocellular Carcinoma
- Localized Non-Resectable Adult Liver Carcinoma
- Recurrent Adult Liver Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Stereotactic Radiosurgery | Undergo SBRT |
Timeline
- Start date
- 2010-10-07
- Primary completion
- 2016-05-09
- Completion
- 2019-05-01
- First posted
- 2013-07-15
- Last updated
- 2022-11-29
- Results posted
- 2020-01-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01899261. Inclusion in this directory is not an endorsement.