Stereotactic Body Radiotherapy for Liver Tumors
This trial is active, not recruiting.
|Conditions||liver metastases, hepatocellular carcinoma, intrahepatic cholangiocarcinoma|
|Treatments||stereotactic body radiosurgery, stereotactic body radiotherapy|
|Sponsor||St. John's Mercy Research Institute, St. Louis|
|Start date||September 2008|
|End date||September 2015|
|Trial size||50 participants|
|Trial identifier||NCT01347333, 08-045|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
local control rate
time frame: 5 years
late complication rates
time frame: 5 years
Male or female participants at least 18 years old.
Inclusion Criteria: - Patient age >= 18 years - Zubrod performance status of 0-3 - Oligometastases (1-3) with aggregate tumor diameter < 6 cm - Metastases from neuroendocrine tumors with functional endocrine syndromes for symptom palliation - Unresectable hepatocellular carcinoma (HCC) - Unresectable intrahepatic cholangiocarcinoma (IHCC) - Maximum tumor diameter < 6 cm - Adequate liver function: Total bilirubin < 3 mg/dL Serum albumin > 2.5 g/dL Serum levels of liver enzymes < 3 times the upper limit of normal Normal PT and PTT unless patient is receiving anticoagulant medication - Signed study-specific consent form Exclusion Criteria: - Maximum tumor diameter > 6 cm - Prior radiotherapy to the liver - Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females - Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
|Official title||Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Liver Metastases and Primary Liver Tumors|
|Description||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.|
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