A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 20, 2022

Interventions

  • Radiation: Adaptive Radiation Therapy

Arms, Groups and Cohorts

  • Experimental: Adaptive Radiation Therapy

Clinical Trial Outcome Measures

Primary Measures

  • The Proportion of Patients for Whom the Intended Treatment Was Feasible
    • Time Frame: 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.
  • Percentage of Patients With Change in Child Pugh Score >= 2
    • Time Frame: 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
    • Time Frame: 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.

Secondary Measures

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

Participating in This Clinical Trial

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:

  • Patients with known allergies to intravenous iodinated contrast agents. – Patients with a contraindication to contrast-enhanced MRI are excluded.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Michigan Rogel Cancer Center
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Theodore Lawrence, M.D., Ph.D., Principal Investigator, Rogel Cancer Center

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