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A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02460835
Recruitment Status : Suspended (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.)
First Posted : June 2, 2015
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Radiation: Adaptive Radiation Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma
Actual Study Start Date : January 26, 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: Adaptive Radiation Therapy Radiation: Adaptive Radiation Therapy



Primary Outcome Measures :
  1. 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.

  2. Incidence of Radiation Induced Liver Disease (RILD) [ Time Frame: 24 months ]
  3. 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 :
  1. 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.


Other Outcome Measures:
  1. Overall Survival [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460835


Locations
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United States, Michigan
Rogel Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48187
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Theodore Lawrence, M.D., Ph.D. Rogel Cancer Center
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT02460835    
Other Study ID Numbers: UMCC 2015.039
HUM00098022 ( Other Identifier: University of Michigan )
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: August 2019
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases