Overview

This trial is active, not recruiting.

Conditions liver metastases, hepatocellular carcinoma, intrahepatic cholangiocarcinoma
Treatments stereotactic body radiosurgery, stereotactic body radiotherapy
Phase phase 4
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes
stereotactic body radiosurgery
36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)
(Other)
Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma
stereotactic body radiotherapy
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)

Primary Outcomes

Measure
local control rate
time frame: 5 years

Secondary Outcomes

Measure
late complication rates
time frame: 5 years

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by St. John's Mercy Research Institute, St. Louis.