NCT01347333

Stereotactic Body Radiotherapy for Liver Tumors

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Mercy Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Metastases
• Hepatocellular Carcinoma
• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
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)
RADIATION	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)

Timeline

• Start date: 2008-09-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2011-05-04
• Last updated: 2020-03-03
• Results posted: 2020-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study