A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Patients must have hepatocellular carcinoma.
Patients must not have extrahepatic cancer.
Patients must not be eligible for a curative liver resection or have refused resection
Patients must have recovered from the acute effects of prior liver-directed therapy and 4 weeks must have passed since the last procedure and protocol therapy.
Patients must have a Zubrod performance status of less than or equal to 2 (Zubrod performance status is a measure that attempts to quantify a cancer patients' general well-being. Scores run from 0 to 5 where 0 denotes normal activity and 5 denotes death).
Patients must be 18 years of age or older.
Patients must have adequate organ function.
Patients must understand and be willing to sign an IRB (Institutional Review Board) approved informed consent form.

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Adaptive Radiation Therapy	Adaptive Radiation Therapy	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Change in Child Pugh Score >= 2	Baseline to approximately 6 months after initiation of SBRT	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.
Median Time to Local Progression	24 months	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.
The Proportion of Patients for Whom the Intended Treatment Was Feasible	At end of treatment; up to ~3 months	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	24 months	Overall survival (OS) is defined as the duration of time from start of treatment to death.
Median Time to Progression	24 months	Defined as the duration of time from start of treatment to time of progression.
Incidence of Grade 3 Gastrointestinal (GI) Bleeding Toxicities	Approximately 6 months	Grade 3 GI bleeding assessed via the NCI CTCAE version 4.0.
Change in ALBI Scores	Approximately 6 months	Liver decompensation assessed by change in ALBI score \> 0.5 from baseline.