The purpose of this study is to determine the maximum tolerated dose of limited fractions of large dose radiation in an effort to achieve a biologically potent cancer therapy in selected patients with primary hepatocellular carcinoma.
Despite recent advances in early detection and diagnosis, only 30-40% of patients with hepatocellular carcinoma may benefit from radical therapies. Liver transplantation offers the best chance for cure. Surgical resection has been the only other potentially curative option, but the majority of patients are not candidates for resection. This reflects the usual comorbidity of severe underlying liver disease that either precludes surgery or makes the surgical approach extremely dangerous.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.
Indiana University Department of Radiation Oncology
Indianapolis, Indiana, United States
Number of Patients With DLTs
Number of patients experiencing a Dose Limiting Toxicity during the Phase I portion of the trial.
Time frame: 6 weeks
6 Month Local In-field Control
Percent of patients and the 95% Binomial Confidence interval who were free of in-field progression at 6 months following treatment for the patients in Phase II
Time frame: 6 months
Time to In-field Failure
Kaplan-Meier Analyses will be used to calculate the median and 95% Confidence Interval for the time until in-field failure. This will be calculated from the time of treatment until the time of in-field failure. If a patient did not have in-field failure, the patient will be censored at their last evaluation date.
Time frame: up to 4 yrs
Overall Survival
Kaplan-Meier Analysis will be used to calculate the median and 95% CI for overall survival. This will be calculated from the time of treatment until death. If a patient did not die, the patient will be censored at their last known alive date.
Time frame: Up to 8 years
Phase II: Number of Patients With Treatment Related Grade 3 or 4 Adverse Events
Number of unique patients who had grade 3 or 4 adverse events that were possibly, probably or definitely related to study treatment.
Time frame: up to 4 years
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