Glioblastoma Multiforme
Conditions
Brief summary
Notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period promoting patient comfort and convenience.
Interventions
Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction)
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients 18 to 70 years of age with newly diagnosed and histologically confirmed glioblastoma. * WHO performance status of 2 or less and adequate hematologic, renal, and hepatic function.
Exclusion criteria
* Prior diagnosis of cancer, unless disease free for \> 3 years * Previous history of radiotherapy in the head and neck region (except initial larynx tumor - T1, T2 / N0M0). * Specific severe, active co-morbidities * Tumor located in the brainstem * Presence of leptomeningeal carcinomatosis * Multicentric tumor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 24 months | From date of the start of treatment to date of death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 24 months | The time between the start of treatment and tumor progression or death due to any cause. |
Countries
Brazil