This trial is active, not recruiting.

Conditions liver cancer, hepatocellular cancer
Treatment individualized stereotactic body radiation therapy (sbrt)
Phase phase 2
Sponsor University of Michigan Cancer Center
Start date October 2009
End date November 2015
Trial size 90 participants
Trial identifier NCT01522937, HUM00029467, UMCC 2009-053


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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).
individualized stereotactic body radiation therapy (sbrt)
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.

Primary Outcomes

Tumor measure rates
time frame: 6 months

Secondary Outcomes

assessment of plasma biomarkers for liver function
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 iodidated 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.

Additional Information

Official title A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
Principal investigator Mary Feng, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Michigan Cancer Center.