This is a pilot single arm study with the primary endpoints of feasibility and preliminary estimates of safety and efficacy. This protocol builds on over 25 years of experience with high dose liver RT (Radiation Therapy), and in particular adaptive RT aimed at adjusting the global radiation dose based on a patient's measured sensitivity to treatment. This current protocol uses functional imaging and specialized radiation planning techniques to spare highly functional portions of the liver to preserve function. The investigators feel this will further improve the safety and efficacy of RT for all patients by customizing treatments to each. If this approach is promising, the investigators will proceed to a phase II randomized study of standard versus spatially and dosimetrically adapted RT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Rogel Comprehensive Cancer Center
Ann Arbor, Michigan, United States
The Proportion of Patients for Whom the Intended Treatment Was Feasible
The primary aim of the trial is feasibility which is defined as the ability to successfully deliver the full treatment including all adaptations and in particular the perfusion-based planning and replanning.
Time frame: At end of treatment; up to ~3 months
Percentage of Patients With Change in Child Pugh Score >= 2
Rate of liver decompensation reported as the percentage of patients with a change in Child Pugh score of greater than or equal to 2 within 6 months of SBRT.
Time frame: Baseline to approximately 6 months after initiation of SBRT
Median Time to Local Progression
The primary efficacy endpoint is local control, measured as the duration of time from start of treatment to time of progression of the treated (target) lesion(s). Patients with no evidence of local progression at the time of data analysis will be censored at the last date on which they were evaluated for local progression. Local progression will be summarized with Kaplan-Meier curves and reported with 95% confidence intervals.
Time frame: 24 months
Median Time to Progression
Defined as the duration of time from start of treatment to time of progression.
Time frame: 24 months
Change in ALBI Scores
Liver decompensation assessed by change in ALBI score \> 0.5 from baseline.
Time frame: Approximately 6 months
Incidence of Grade 3 Gastrointestinal (GI) Bleeding Toxicities
Grade 3 GI bleeding assessed via the NCI CTCAE version 4.0.
Time frame: Approximately 6 months
Overall Survival
Overall survival (OS) is defined as the duration of time from start of treatment to death.
Time frame: 24 months
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