Stereotactic Body Radiotherapy for Liver Tumors

Mercy Research

Status: Completed

Conditions: Intrahepatic Cholangiocarcinoma; Hepatocellular Carcinoma; Liver Metastases

Treatments: Radiation: Stereotactic Body Radiotherapy; Radiation: Stereotactic body radiosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01347333

08-045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

liver metastases

Other group

Description:

Oligometastases (1-3) with aggregate tumor diameter \< 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes

Treatment:

Radiation: Stereotactic body radiosurgery

Primary Liver Tumors

Other group

Description:

Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma

Treatment:

Radiation: Stereotactic Body Radiotherapy