A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer

Study Overview
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Brief Summary
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This is a Phase II trial to characterize the safety and efficacy of individualized stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment or who have primary hepatocellular carcinoma (HCC).

Detailed Description
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The trial endpoints are toxicity, survival and progression-free survival. DCE-MRI and plasma biomarkers will also be collected to explore their use as tools for treatment individualization in future trials. During the current trial, an indicator of liver function, indocyanine green (ICG), will be used to identify during treatment patients who are at excess risk for radiation-induced liver disease (RILD) so that their radiation dose may be reduced. The model used for individualization will be updated as trial data accrue, so this is an adaptive trial of an individualized therapy. The planned accrual is seventy (70) evaluable patients over three years.

Official Title
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A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer

Conditions
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Liver Cancer, Hepatocellular Cancer

Intervention / Treatment
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* Radiation: individualized Stereotactic Body Radiation Therapy (SBRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over age 18 life expectancy of at least 12 weeks Zubrod performance status of ≤2. biopsy proven hepatocellular carcinoma (HCC) liver metastases a discrete hepatic tumor(s) as defined by the Barcelona46 criteria - for cirrhotic patients, (1) 2 imaging studies showing hypervascular tumor > 2cm, or (2) single imaging study showing hypervascular tumor > 2cm with AFP ≥ 400 ng/mL a discrete hypervascular tumor present on two consecutive imaging studies (CT or MRI) with documented growth of > 1cm in diameter adequate organ function women and men not interested in pregnancy must be recovered from the effects of any prior surgery, radiation therapy, chemotherapy and the effects of Radiofrequency Ablation (RFA) or Transcatheter Arterial Chemo Embolization (TACE) minimum of 6 weeks following their last surgical procedure, radiation and chemotherapy. Exclusion Criteria: cannot be eligible for a curative liver resection uncontrolled ascites clinically evident on physical exam known allergy to IC-Green known allergy to intravenous iodinated contrast agents patients with poor venous access patients with metastatic cancer with normal liver function who have not undergone previous liver directed therapy and a single tumor < 6 cm in size.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liver cancer patients<br>The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC). | Radiation: individualized Stereotactic Body Radiation Therapy (SBRT)<br>* The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Patients With Local Control at 1 Year Post Treatment | For this study, local control is defined as the lack of progressive local disease following CR (Complete Response) or PR (Partial Response), or lack of progressive local disease in patients with non-evaluable disease, who have no progressive elevation in serum tumor markers. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Patients Alive Without Progression at 1 Year | Progression is defined as a greater than or equal to 20% growth of a lesion from the smallest lesion measurement | 1 Year | 
| The Percentage of Patients Alive at 1 Year |  | 1 Year | 
| The Number of Patients Who Experience Grade 4+ Hepatotoxicity | Grade 4 toxicities are life threatening toxicities that require urgent attention. | 1 Year | 
| The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding | Grade 4 toxicities are life threatening toxicities that require urgent attention. | 1 Year |