Glioma
Conditions
Keywords
HGG
Brief summary
To assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed HGG.
Detailed description
Investigators designed this study with the aim to assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed HGG. The potential advantage of this approach is deliver a more selective irradiation to tumor's target with reducing the dose to normal brain and to allow the delivery of a higher dose, optimizing the therapeutic window.
Interventions
RADIATIONRadiation
hypofractionated IMRT
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥ 70 years * Karnosky performance status (KPS) ≤60 * Histologically confirmed HGG after tumor biopsy * GBM * Anaplastic Astrocytoma * Anaplastic Oligoastrocytoma * Anaplastic Oligodendroglioma without IDH1 mutation and no codeletion 1p19q * Estimated survival ≥ 3 months. * Normal liver, Kidney and bone marrow function * Written informed consent
Exclusion criteria
* Prior radiation therapy * Other primary cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | one year | Progression free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | one year | Overall Survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | one year | Incidence of hematologic and non hematologic severe toxicities (grade III/ IV) will evaluate using NCI-CTCA scale. Late toxicity will evaluate using CTCA 4.2 |
| QoL | one year | Quality of Life |
Countries
Italy
Outcome results
None listed