Stereotactic Body Radiotherapy for Liver Tumors

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347333
• Other study ID #: 08-045
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: September 2016

Study information

• Verified date: February 2020
• Source: Mercy Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Hepatocellular Carcinoma
• Intrahepatic Cholangiocarcinoma
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• Stereotactic body radiosurgery
36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)
• 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)

Locations

Country	Name	City	State
United States	St. John's Mercy Medical Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Late Complication Rates	Toxicities will be assessed using CTCAE grading criteria at specified timepoints.	5 years