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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Undergo SBPT
Ancillary studies
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
3-month rate of patients experiencing an increase in Child-Pugh score by 2 or more points of 5-fraction stereotactic body proton radiotherapy in the treatment of hepatocellular carcinoma (HCC)
The rate will be estimated and a 95% exact binomial confidence interval reported, and then tested utilizing a one-sample test for proportions versus the historical control of 15%.
Time frame: 3 months
3-month complication rate
Defined by grade 3 or higher acute adverse event. Will be calculated and presented with 95% confidence intervals (CI), while continuous outcomes will be presented with mean, median, 95% CI, and interquartile range (IQR).
Time frame: 3 months
Incidence of late toxicity
Defined by grade 3 or higher acute adverse event.
Time frame: Up to 2 years
6-month local control
Will be reported via Kaplan-Meier estimates.
Time frame: 6 months
Liver disease control
Will be reported via Kaplan-Meier estimates.
Time frame: Up to 2 years
Progression free survival
Will be reported via Kaplan-Meier estimates.
Time frame: Up to 2 years
Overall survival
Will be reported via Kaplan-Meier estimates.
Time frame: Up to 2 years
Imaging response rates
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Will be determined by Modified (m) Response Evaluation Criteria in Solid Tumors (RECIST) and RECIST criteria. Will be calculated and presented with 95% CI, while continuous outcomes will be presented with mean, median, 95% CI, and IQR.
Time frame: 6 months
Value of volumetric imaging analysis
Will be compared to mRECIST and RECIST in the setting of HCC treated with stereotactic body radiotherapy (SBRT).
Time frame: 6 months