Image Guided Reirradiation of High-grade Glioma
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
The purpose of the study is to evaluate the short- and long term toxicity of radiotherapy to patients with recurrent high-grade glioma who have previously received radiotherapy and to determine the best dose and treatment regimen. Positron emission tomography (PET) using an amino acid tracer, 18-fluoro-ethyltyrosine (18F-FET), is used for target delineation.The study examines, in four sequential treatment groups, the effect of dose, hypofractionation and treatment volume on toxicity. Upon completion of the phase I part, the study progresses to phase II where the best dose- and treatment regimen will be chosen for treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- recurrent high-grade glioma
- previous focal radiotherapy for high-grade glioma
- no standard treatment options available/indicated
- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1 or 2
- life expectancy > 3 months
- hemoglobin value > 6 mmol/l (transfusion permitted)
- able to understand oral and written Danish
Exclusion criteria
- disseminated recurrent disease
- infection or wound dehiscence or other pathological condition in meninges/skull/scalp
- symptoms of elevated intracranial pressure
- very early recurrence following primary radiotherapy (< or equal to 3 months)
- contraindications to magnetic resonance imaging (MRI) or positron emission tomography (PET)
- other previous radiotherapy to the brain than primary course of irradiation
Trial design
Primary purpose
Allocation
Interventional model
Masking
31 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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