Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Liver Metastases and Primary Liver Tumors
This study is a single site, non-randomized, prospective, phase IV trial.
Composed of 4 patient groups:
1. Oligometastases (1-3) with aggregate tumor diameter < 6 cm
2. Metastases from neuroendocrine tumors with functional endocrine syndromes
3. Unresectable hepatocellular carcinoma (HCC)
4. Unresectable intrahepatic cholangiocarcinoma (IHCC) Data collected will include patient
demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose
received by adjacent critical normal tissues, tumor recurrence data, and acute and late
toxicities. Follow up data will be collected during the patient's standard office
visits. The anticipated duration of this study is 5 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
local control rate
Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques, physical exam and biopsy, if applicable. If necessary, a PET/CT scan may be used to aid in the diagnoses of local tumor recurrence.
Bethany G Sleckman, MD
Mercy Hospital St. Louis
United States: Institutional Review Board
|St. John's Mercy Medical Center||Saint Louis, Missouri 63141|