Status:
COMPLETED
A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Liver Cancer
Hepatocellular Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 hep...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01522937
Start Date
October 1 2009
End Date
November 1 2015
Last Update
March 9 2017
Active Locations (1)
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1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-5010