A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT02460835
Recruitment Status :
(Enrollment and/or interactions/interventions temporarily paused due to COVID-19 and expected to resume in the future. This is not a suspension of IRB approval.)
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.
The number of patients for whom the intended treatment was feasible [ Time Frame: 6 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.
Incidence of Radiation Induced Liver Disease (RILD) [ Time Frame: 24 months ]
Median Time to Progression [ Time Frame: 24 months ]
The primary efficacy endpoint is local control, measured as the time to progression of the treated lesion. 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.
Secondary Outcome Measures :
Time to progression [ Time Frame: 24 months ]
The primary efficacy endpoint is local control, measured as the time to progression of the treated lesion. The estimated rate of local control will be estimated and reported with 95% confidence intervals.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Patients with known allergies to intravenous iodinated contrast agents.
Patients with a contraindication to contrast-enhanced MRI are excluded.