NCT01247298

A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma

RAD 0902: A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This investigational study will evaluate if using a combination of TACE along with high dose SBRT would show improvement in local control in patients with Hepatocellular Carcinoma.

Detailed description

Primary objectives of this research 1. Evaluate the safety of a combination of TACE and high dose SBRT 2. Measure time to progression (TTP) and local recurrence rate of HCC treated with a combination of TACE \& SBRT. Secondary objectives of this research 1. Assess failure patterns and survival of patients treated with TACE \& SBRT. 2. Analyze dose volume characteristics that influence Radiation Induced Liver Disease (RILD) among patients treated with a combination of TACE and SBRT.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Stereotactic Body Radiation Therapy (SBRT)	This investigational study will evaluate the combination of TACE along with high dose SBRT. TACE has been used extensively in the palliative treatment of hepatocellular carcinoma (HCC). It will be performed by the Interventional Radiologist prior to radiation therapy.

Timeline

• Start date: 2010-10-01
• Primary completion: 2016-09-01
• Completion: 2016-12-01
• First posted: 2010-11-24
• Last updated: 2017-08-21
• Results posted: 2017-06-19

Locations

1 site across 1 country: United States