This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy for the treatment of liver metastases and unresectable primary liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)
26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)
St. John's Mercy Medical Center
St Louis, Missouri, United States
Local Tumor Recurrence Rate
Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.
Time frame: 5 years
Late Complication Rates
Toxicities will be assessed using CTCAE grading criteria at specified timepoints.
Time frame: 5 years
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