Study of Gamma-Knife Radiosurgery Using Magnetic Resonance Imaging (MRI) Spectroscopy for Recurre… (NCT01011231) | Clinical Trial Compass
TerminatedPhase 2
Study of Gamma-Knife Radiosurgery Using Magnetic Resonance Imaging (MRI) Spectroscopy for Recurrent Glioma
Stopped: low accrual
United States1 participantsStarted 2009-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically confirmed glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, malignant glioma not otherwise specified, low-grade astrocytoma, low-grade oligodendroglioma, low-grade oligoastrocytoma, or low-grade glioma not otherwise specified.
. Prior first-line treatment with surgery or biopsy followed by fractionated radiotherapy with concurrent temozolomide-containing chemotherapy is required for malignant (grade III or IV) glioma patients. Additional prior chemotherapy is allowed, without limitation on number of recurrences. In patients with low-grade tumors, neither prior radiotherapy nor prior chemotherapy is required.
. An interval of \> 2 months since completion of fractionated radiotherapy.
. Age \> 18 years
. Life expectancy of at least 8 weeks.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
. Karnofsky Performance Status score (KPS) of ≥ 60
. Documented recurrent disease: Recurrent disease is defined either as histological confirmation of tumor, as an increase in tumor size of at least 25% based upon serial MR images, or as development of a new site of disease.
. Eligibility for gamma-knife radiosurgery: The decision to treat with gamma-knife radiosurgery will be made by a consensus of the radiation oncology, neurosurgery and neuro-oncology co-chairs or their alternates at the weekly Brain Tumor or Gamma-Knife Tumor Conferences. The MRS defined target volume must be ≤ 15 cc. and not involving eloquent brain (speech/language cortex, motor/sensory cortex, basal ganglia, brainstem, or corpus callosum 2) on an MRI done within 14 days of the planned GKS procedure.
Exclusion criteria
. MRS defined tumor volume greater than 15 cc.
. MRS defined tumor volume involving eloquent brain (speech/language cortex, motor/sensory cortex, basal ganglia, brainstem, or corpus callosum).
. Concurrent treatment with chemotherapy.
. Active infectious process requiring IV antibiotics.
. History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of three years.
. Other major medical illness judged by the investigator to preclude prolonged follow-up.
. Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator.