recurrent brain tumor recurrent high grade glioma
Conditions
Interventions
The entire group will receive 4 stereotactic fractions of radiotherapy. The
historical control group received 10 fractions with a similar biologically
equivalent dose.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Supratentorial recurrent high-grade glioma with contrast enhancement on CE-T1 • The gold standard is histological evidence of a recurrence. When a surgical procedure to acquire this evidence is not desirable or possible, a recurrence may be diagnosed by radiological imaging alone, taking the following in consideration: o Agreement of the tumor board or a consultant neuro-radiologist that imaging changes are in keeping with recurrence. o An interval of no less than 3 months since last (chemo)radiotherapy. o Utilization of the RANO criteria for tumor progression. o If needed, additional imaging sequences such as PET and perfusion MRI. • Unifocal glioma (i.e. lesions clustering around residual surgical cavity) • Prior course of treatment including radiotherapy with an EQD2 (a/β = 2) of at least 47Gy • Age >= 18 years • Karnofsky Performance Score 60 or above • Ability of subject to understand character and individual consequences of the clinical trial (arm1) • Patients who received re-irradiation for the recurrence of a primary brain tumor with a treatment schedule of 10x3.5Gy (arm 2).
Exclusion criteria
Exclusion criteria: • Previous re-irradiation or prior radiosurgery or prior treatment with interstitial radioactive seeds. • CE-T1 tumor diameter greater than 6cm (~reflecting a spherical tumor of 125cc ). • Time interval of less than 6 months after prior radiotherapy. • Time interval of less than 3 weeks after last re-resection (1 week for biopsy). • Known carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is overall survival after re-irradiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary endpoint is HRQoL. Other secondary endpoints are recurrence patterns, progression free survival, toxicity and anti-edema treatment. | — |
Countries
Netherlands
Outcome results
None listed