Phase I Study of Whole Brain Radiation Therapy With Simultaneous Boost to Gross Metastatic Tumor Volume Using Volumetric Modulated Arc Therapy (VMAT)
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
The MTD will be defined as either the dose when a grade 3 or greater toxicity judged to be at least possibly due to the treatment develops in 2 of 6 patients in a dose group within 3 months of the treatment or the highest dose level (group 3) if < 2 of 6 patients develop a grade 3 or greater toxicity judged to be at least possibly due to the treatment at that dose within 3 months of treatment. If > 2 of 6 patients develop a grade 3 or greater toxicity at a dose level, the dose is de-escalated to the prior group and that group is expanded to 6 patients.
Hui-Kuo Shu, MD Phd
United States: Institutional Review Board
|Emory University Winship Cancer Institute||Atlanta, Georgia 30322|
|Emory University Hospital Midtown||Atlanta, Georgia 30308|