A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
18 Years
N/A
Both
Liver Cancer, Hepatocellular Cancer
Trial Information
A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor measure rates
Outcome Description:
Tumor size will be measured every 2 months following treatment to assess for shrinkage, stability of size, or increasing size. Adverse events will also be monitored every 2 months to assess for safety.
Outcome Time Frame:
6 months
Safety Issue:
Yes
Principal Investigator
Mary Feng, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Michigan Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
UMCC 2009-053
NCT ID:
NCT01522937
Start Date:
October 2009
Completion Date:
January 2016
Related Keywords:
- Liver Cancer
- Hepatocellular Cancer
- Liver Neoplasms
Name | Location |
|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
