Phase II Study of Gamma-Knife Radiosurgery Using Magnetic Resonance Spectroscopy for Target Definition in Patients With Recurrent Glioma
Study Design: A single-center, single-arm, one-stage phase II clinical trial for patients
with recurrent grade IV glioma (glioblastoma), with two additional exploratory arms for
patients with recurrent grade II and grade III gliomas.
Patient Numbers: A total of 40 patients with recurrent glioblastoma will be enrolled. In
addition, a minimum of 10 patients with recurrent grade III (anaplastic) glioma and a
minimum of 10 patients with recurrent grade II (low-grade) glioma will be enrolled
independently into separate exploratory arms.
Summary of Patient Eligibility Criteria Histological confirmation of glioma, grades II - IV;
prior first-line treatment with surgery, radiotherapy and chemotherapy for malignant (grades
III and IV) gliomas; age > 18 years; life expectancy >8 weeks; Karnofsky Performance Status
≥ 60; adequate organ function; signed patient informed consent; willingness to forego
additional therapy until evidence of disease progression.
Primary: Six-month progression-free survival (PFS-6)
Secondary: Median overall survival (mOS), median progression-free survival (mPFS),
location of recurrence, symptomatic necrosis rate, reoperation rate, reoperation findings
(estimated percentage of viable tumor vs. radiation effect and necrosis), and safety
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the efficacy, as measured by progression-free survival at six months (PFS-6), of treating patients with recurrent glioblastoma using GKS to target a tumor volume defined by a combination of gadolinium enhancement and MRS.
Jennifer Clarke, MD, MPH
UCSF Department of Neurosurgery
United States: Institutional Review Board
|UCSF Department of Neurosurgery||San Francisco, California 94143|