Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
OBJECTIVES: * Determine the maximum tolerated dose of brachytherapy administered via GliaSite RTS™ applicator followed by external beam radiotherapy in patients with newly diagnosed glioblastoma multiforme. * Determine the acute and chronic toxicity of brachytherapy administered via GliaSite RTS™ in these patients. * Determine the survival rate of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of brachytherapy. Patients undergo craniotomy for histologic confirmation of glioblastoma multiforme, surgical resection, and placement of a GliaSite RTS™ applicator that includes Iotrex™. Beginning 3-21 days after surgery, patients undergo brachytherapy via the GliaSite RTS™ applicator. Within 30 days of brachytherapy (no more than 60 days after resection) patients undergo external beam radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 or 3 of 10 patients experience dose-limiting toxicity. Patients are followed at 21-35 days, every 2 months for 1 year, and then for survival. PROJECTED ACCRUAL: A total of 15-100 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
