Using Prednisone to Protect the Liver During Radiation Therapy for Liver Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the use of Prednisone to protect the liver in patients undergoing Stereotactic Body Radiation Therapy (SBRT) for hepatocellular carcinoma. Participants will self-administer Prednisone for three days prior to starting radiation therapy and continue taking it during the initial phases of treatment. The goal is to assess whether this approach can mitigate liver damage associated with radiation. The study focuses on patients who have specific criteria related to their liver cancer and overall health status.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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.

Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.

* 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.

Where it's running

• Rogel Comprehensive Cancer Center
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Theodore Lawrence — University of Michigan Rogel Cancer Center
• Study coordinator: Theodore Lawrence
• Email: tsl@med.umich.edu
• Phone: 7346479955

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.