RECRUITING

A Pilot Study of Liver Protection Using Prednisone for Patients Receiving Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

Conditions

Hepatocellular Carcinoma Radiation Therapy Prednisone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients on this study will self administer Prednisone for three days before starting Radiation Therapy (RT) and continue to take 60 mg/day during the first three fractions of RT.

Official Title

A Pilot Study of Liver Protection Using Prednisone for Patients Receiving Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

Quick Facts

Study Start:2024-02-16

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05901519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients with hepatocellular carcinoma are eligible for this trial. Hepatocellular carcinoma is defined as having at least one of the following: 1. Biopsy proven hepatocellular carcinoma (HCC); or 2. A discrete hepatic tumor(s) as defined by the AASLD criteria (80) - for cirrhotic patients, \>1cm with arterial hypervascularity and venous or delayed phase washout on contrast enhanced CT or MRI. * Patients must have recovered from the acute effects of prior liver-directed therapy (e.g., RT, RFA, or TACE), and a minimum of 4 weeks must have passed since the last procedure and protocol therapy. * Patients must have a performance status of ≤2. * Patients must be 18 years of age or older. * Patients with at least one of the following: 1. ALBI score equal to (-1.81) or higher (worse). This value was calculated as the equivalent ALBI score for CP score equal 7 in Cousins et al study's cohort(59). 2. Lesion(s) with a cumulative treatment diameter of ≥ 4cm. 3. CP score equal to 7 or higher (worse). * Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.	* Any serious disease, comorbidity or intercurrent illness which precludes delivery of radiation therapy, as determined by the treating investigator. * Any contraindication to the administration of steroids, including * Documented hypersensitivity to prednisone or any component of the formulation. * Systemic fungal infection. * Patients with uncontrolled infections or with chronic infections requiring antibiotics. * Uncontrolled hyperglycemia. * Patients with insulin -dependent diabetes. * Patients with decompensated liver disease, defined as: clinical ascites requiring paracentesis, hepatic encephalopathy, hepatorenal syndrome or variceal hemorrhage. * Active gastrointestinal bleeding within 30 days of enrollment.

Inclusion Criteria

Exclusion Criteria

* Patients with hepatocellular carcinoma are eligible for this trial. Hepatocellular carcinoma is defined as having at least one of the following:
1. Biopsy proven hepatocellular carcinoma (HCC); or
2. A discrete hepatic tumor(s) as defined by the AASLD criteria (80) - for cirrhotic patients, \>1cm with arterial hypervascularity and venous or delayed phase washout on contrast enhanced CT or MRI.
* Patients must have recovered from the acute effects of prior liver-directed therapy (e.g., RT, RFA, or TACE), and a minimum of 4 weeks must have passed since the last procedure and protocol therapy.
* Patients must have a performance status of ≤2.
* Patients must be 18 years of age or older.
* Patients with at least one of the following:
1. ALBI score equal to (-1.81) or higher (worse). This value was calculated as the equivalent ALBI score for CP score equal 7 in Cousins et al study's cohort(59).
2. Lesion(s) with a cumulative treatment diameter of ≥ 4cm.
3. CP score equal to 7 or higher (worse).
* Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.

* Any serious disease, comorbidity or intercurrent illness which precludes delivery of radiation therapy, as determined by the treating investigator.
* Any contraindication to the administration of steroids, including
* Documented hypersensitivity to prednisone or any component of the formulation.
* Systemic fungal infection.
* Patients with uncontrolled infections or with chronic infections requiring antibiotics.
* Uncontrolled hyperglycemia.
* Patients with insulin -dependent diabetes.
* Patients with decompensated liver disease, defined as: clinical ascites requiring paracentesis, hepatic encephalopathy, hepatorenal syndrome or variceal hemorrhage.
* Active gastrointestinal bleeding within 30 days of enrollment.

Contacts and Locations

Study Contact

Theodore Lawrence

CONTACT

7346479955

tsl@med.umich.edu

Principal Investigator

Theodore Lawrence

PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Study Locations (Sites)

Rogel Comprehensive Cancer Center

Ann Arbor, Michigan, 48187

United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

Theodore Lawrence, PRINCIPAL_INVESTIGATOR, University of Michigan Rogel Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-16

Study Completion Date2026-08

Study Record Updates

Study Start Date2024-02-16

Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

Radiation Therapy
Prednisone

Additional Relevant MeSH Terms

Hepatocellular Carcinoma