Glioblastoma Clinical Trial
Official title:
Phase II Study of Gamma-Knife Radiosurgery Using Magnetic Resonance Spectroscopy for Target Definition in Patients With Recurrent Glioma
The purpose of this study is to assess the efficacy, of treating patients with recurrent
glioblastoma using Gamma-Knife Radiosurgery (GKS) to target a tumor volume defined by a
combination of gadolinium enhancement and magnetic resonance spectroscopy (MRS). This is a
single center, Phase II trial. A total of 40 glioblastoma patients will be enrolled into the
primary arm of the trial. In addition, a minimum of 10 patients with recurrent anaplastic
(grade III) gliomas and a minimum of 10 patients with recurrent low-grade (grade II) gliomas
will be enrolled into exploratory arms.
The investigators hypothesize that the use of a combination of gadolinium enhancement and
elevated Cho:NAA ratio via MRS to determine the treatment target volume for Gamma Knife may
be an effective way to treat focally-recurrent glioblastoma.
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.
End Points
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
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