Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot be Removed by Surgery or Transplant
| Status: | Archived |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | August 2010 |
Downstaging of Hepatocellular Carcinoma by Stereotactic Body Radiotherapy for Non-Resectable and Non-Transplantable Tumors: Phase 2 Study
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Stereotactic
body radiation therapy may be able to send x-rays directly to the tumor and cause less
damage to normal tissue in patients with liver cancer. Giving stereotactic body radiation
therapy may also increase patient eligibility for liver transplant.PURPOSE: This phase II
trial is studying how well stereotactic body radiation therapy works in treating patients
with liver cancer that cannot be removed by surgery or transplant.
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.
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