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Trial Title:
A Pilot Study of Liver Protection Using Prednisone for Patients Receiving Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma
NCT ID:
NCT05901519
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Prednisone
Conditions: Keywords:
Radiation Therapy
Prednisone
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Prednisone
Description:
Patients will be treated with PO prednisone, once a day, at a dose of 60 mg/day
Arm group label:
Patients treated with Prednisone
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Rogel Comprehensive Cancer Center
Address:
City:
Ann Arbor
Zip:
48187
Country:
United States
Status:
Recruiting
Contact:
Last name:
Theodore Lawrence, M.D., Ph.D.
Investigator:
Last name:
Theodore Lawrence, M.D., Ph.D.
Email:
Principal Investigator
Start date:
February 16, 2024
Completion date:
August 2026
Lead sponsor:
Agency:
University of Michigan Rogel Cancer Center
Agency class:
Other
Source:
University of Michigan Rogel Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05901519
