NCT03812289

Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

A Pilot Study to Assess Feasibility of Hypofractionation and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well stereotactic body radiation therapy works in treating patients with liver cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Detailed description

PRIMARY OBJECTIVE: I. Assess the use of stereotactic body radiation therapy (SBRT) in hepatocellular carcinoma (HCC) patients with advanced liver cirrhosis as a feasible approach to providing localized disease control that adequately suffices liver transplant eligibility criteria. SECONDARY OBJECTIVE: I. Assess preliminary efficacy and toxicity in HCC patients with advanced cirrhosis following liver SBRT. EXPLORATORY OBJECTIVE: I. Assess qualify of life in HCC patients with advanced cirrhosis following liver SBRT. OUTLINE: Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 6 weeks, then every 3 months for up to 2 years.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT

Timeline

• Start date: 2019-02-07
• Primary completion: 2024-01-11
• Completion: 2024-01-11
• First posted: 2019-01-23
• Last updated: 2025-03-07
• Results posted: 2025-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study