A Phase I/II Dose-Finding Study of Single-Fraction Stereotactic Body Radiotherapy (SF-SBRT) for the Treatment of Liver Metastases
OUTLINE: This is a phase I/II, dose-escalation study.
Phase I: Patients undergo either percutaneous placement of metallic fiducial markers within
the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting
and planning. Patients then undergo single-fraction stereotactic body radiotherapy over
approximately 1 hour within 1 week of the marker placement.
Phase II: Patients undergo treatment as in phase I at the maximum tolerated dose. After
completion of study treatment, patients will be followed at weeks 4 and 12 and then every 3
months for 2 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.
Robert C. Miller, M.D.
United States: Food and Drug Administration
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