Study of Gamma-Knife Radiosurgery Using Magnetic Resonance Imaging (MRI) Spectroscopy for Recurrent Glioma (GKS)
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|ClinicalTrials.gov Identifier: NCT01011231|
Recruitment Status : Terminated (low accrual)
First Posted : November 11, 2009
Last Update Posted : May 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Procedure: Gamma Knife Radiosurgery||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Gamma-Knife Radiosurgery Using Magnetic Resonance Spectroscopy for Target Definition in Patients With Recurrent Glioma|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
- Procedure: Gamma Knife Radiosurgery
Patient treatments will be planned with the Gamma Plan software. The dose will be prescribed to the isodose surface which encompasses the target volume within a range of 50-60% based on a local maximum of 100%. Radiosurgery dose will be prescribed based on volume within the prescribed isodose surface (not to exceed 18 cc)
- 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. [ Time Frame: 6 months ]
- To describe PFS and OS in pts with recurrent GBM following GKS targeting a tumor volume defined by a combination of gad enhancement and MRS [ Time Frame: 1 year ]
- To further assess the safety of GKS in patients with recurrent glioblastoma [ Time Frame: 1 year ]
- To gather initial data regarding the safety and efficacy of treatment of patients with recurrent low-grade or anaplastic glioma with GKS targeting a tumor volume as defined by a combination of gadolinium enhancement and MRS. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011231
|United States, California|
|UCSF Department of Neurosurgery|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Jennifer Clarke, MD, MPH||UCSF Department of Neurosurgery|