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Completed

NCT Number: NCT02460835

A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rogel Comprehensive Cancer Center

Ann Arbor, Michigan, 48187, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adaptive Radiation Therapy

Radiation

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. Median Time to Progression

    Time frame: 24 months

    Defined as the duration of time from start of treatment to time of progression.

  2. Change in ALBI Scores

    Time frame: Approximately 6 months

    Liver decompensation assessed by change in ALBI score > 0.5 from baseline.

  3. 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.

  4. Overall Survival

    Time frame: 24 months

    Overall survival (OS) is defined as the duration of time from start of treatment to death.

Other outcomes

  1. Incidence of Radiation Induced Liver Disease (RILD)

    Time frame: 24 months

    RILD is a rare but serious side effect that will be summarized if it occurs.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 2, 2015
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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