Downstaging of Hepatocellular Carcinoma by Stereotactic Body Radiotherapy for Non-Resectable and Non-Transplantable Tumors: Phase 2 Study
PRIMARY OBJECTIVES:I. To determine in patients with stage B and C Hepatocellular Carcinoma,
if Stereotactic Body Radiotherapy can achieve a downstaging rate of >= 30% at 3
months.SECONDARY OBJECTIVES:I. To determine in patients with stage B and C Hepatocellular
Carcinoma, if Stereotactic Body Radiotherapy can achieve a downstaging rate of >= 30% at 3
and 6 months.II. To determine the rate of Grade 3 or 4 adverse events associated with SBRT
for liver tumors. III. To determine the rate of local progression after SBRT. (Based
onRECIST criteria)IV. To determine the number of patients who achieve liver
transplantation.OUTLINE:Patients undergo 3 fractions of stereotactic body radiation therapy
delivered within 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of downstaging of stage B and C Hepatocellular Carcinoma using Stereotactic Body Radiotherapy
At 3 months
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government