Stereotactic Body Radiotherapy for Liver Tumors

Not Applicable

Completed

Conditions: Hepatocellular Carcinoma
Liver Metastases
Intrahepatic Cholangiocarcinoma

Registration Number: NCT01347333

Lead Sponsor: Mercy Research

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Local Tumor Recurrence Rate	5 years	Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.

Secondary Outcome Measures

Name	Time	Method
Late Complication Rates	5 years	Toxicities will be assessed using CTCAE grading criteria at specified timepoints.

Trial Locations

Locations (1): St. John's Mercy Medical Center
🇺🇸
Saint Louis, Missouri, United States
St. John's Mercy Medical Center
🇺🇸Saint Louis, Missouri, United States