Phase 2
N=146
A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
Liver Cancer · Hepatocellular Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01522937 ↗Enrolled (actual)
146
Serious AEs
15.1%
Results posted
Mar 2017
Primary outcome: Primary: The Percentage of Patients With Local Control at 1 Year Post Treatment — 99 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- individualized Stereotactic Body Radiation Therapy (SBRT) (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Patients With Local Control at 1 Year Post Treatment |
99 | — |
| SECONDARY The Percentage of Patients Alive Without Progression at 1 Year |
62 | — |
| SECONDARY The Percentage of Patients Alive at 1 Year |
67 | — |
| SECONDARY The Number of Patients Who Experience Grade 4+ Hepatotoxicity |
— | — |
| SECONDARY The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding |
— | — |
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 hepatocellular carcinoma (HCC).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01522937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.