Image Guided Reirradiation of High-grade Glioma

Image Guided Reirradiation of High-grade Glioma - a Phase I/II Dose Escalation Study

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.

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