Recurrent High Grade Glioma
Conditions
Brief summary
The study is aimed to evaluate efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.
Detailed description
Investigators designed this study of a re-irradiation with single radiosurgery or hypofractionated intensity modulated radiation therapy (IMRT) with or without temozolomide. Objective of the study is evaluating efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.
Interventions
RADIATIONIMRT with or without radiosensitive therapy
Re-irradiation with hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc
DRUGRadiosensitive therapy
Radiosensitive therapy with Temozolomide
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Karnosky performance status (KPS) ≥70 * Patients aged \>70 years with KPS ≥80 * Histopathologically confirmed grade III-IV glioma * Estimated survival ≥ 3 months * Any Tumor volume * Unifocal tumor * Interval time from previous radiotherapy ≥ 6mesi * Normal liver, Kidney and bone marrow function * Written informed consent
Exclusion criteria
* KPS \< 70 * Multifocal tumor * Other primary cancer * Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free of participants | 4 years |
| Overall survival of participants | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of radionecrosis | 3 months |
| Questionnaire assessment of neurocognitive function | 6 months |
Countries
Italy
Outcome results
None listed