NCT04805788

Stereotactic Body Proton Radiotherapy for the Treatment of Liver Cancer

A Phase II Single Arm Trial of Stereotactic Body Proton Radiotherapy (SBPT) for Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the effect of stereotactic body proton radiotherapy in treating patients with liver cancer. Proton radiotherapy is a type of treatment that uses high-energy beams to treat tumors.

Detailed description

PRIMARY OBJECTIVE: I. To determine the 3-month rate of patients experiencing an increase in Child-Pugh (CP) score by 2 or more points of 5-fraction stereotactic body proton radiotherapy (SBPT) in the treatment of hepatocellular carcinoma (HCC). SECONDARY OBJECTIVES: I. To determine the 3-month complication rate as defined by grade 3 or higher acute adverse event. II. To assess late toxicity with 2 year follow-up. III. To estimate the 6-month local control, liver disease control, progression free survival and overall survival. IV. To determine objective imaging response rates at 6 months by Modified (m) Response Evaluation Criteria in Solid Tumors (RECIST) and RECIST criteria. V. To determine the value of volumetric imaging analysis compared to mRECIST and RECIST in the setting of HCC treated with stereotactic body radiotherapy (SBRT). CORRELATIVE AND EXPLORATORY OBJECTIVES: I. To evaluate patient-reported outcomes. II. To evaluate clinical features, treatment technique, and dose-volume parameters associated with better local control and fewer adverse events. III. To determine the value of additional imaging analyses and techniques for assessing tumor response after treatment with SBRT IV. To blood bank patient specimens for future analysis. OUTLINE: Patients undergo 1 SBPT fraction over 20-30 minutes per day for a total of 5 fractions. After completion of study treatment, patients are followed up at 2 weeks, 3 , 6, 12 and 24 months, then annually for 3 years.

Conditions

• Recurrent Hepatocellular Carcinoma
• Stage I Hepatocellular Carcinoma AJCC v8
• Stage II Hepatocellular Carcinoma AJCC v8
• Stage III Hepatocellular Carcinoma AJCC v8

Interventions

Type	Name	Description
RADIATION	Proton Stereotactic Body Radiation Therapy	Undergo SBPT
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2021-08-24
• Primary completion: 2024-02-15
• Completion: 2025-01-28
• First posted: 2021-03-18
• Last updated: 2025-12-31

Locations

2 sites across 1 country: United States