Stereotactic Body Radiotherapy for Liver Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is a single site, non-randomized, prospective, phase IV trial. Composed of 4 patient groups: Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes Unresectable hepatocellular carcinoma (HCC) 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.

Official Title
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Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Liver Metastases and Primary Liver Tumors

Conditions
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Liver Metastases, Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma

Intervention / Treatment
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* Radiation: Stereotactic body radiosurgery
* Radiation: Stereotactic Body Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: liver metastases<br>Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes | Radiation: Stereotactic body radiosurgery<br>* 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)<br>|
| Other: Primary Liver Tumors<br>Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma | Radiation: Stereotactic Body Radiotherapy<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Tumor Recurrence Rate | Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Complication Rates | Toxicities will be assessed using CTCAE grading criteria at specified timepoints. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver metastases, stereotactic radiotherapy