Health Condition 1: G94- Other disorders of brain in diseases classified elsewhere Health Condition 2: G938- Other specified disorders of brain
Conditions
Interventions
Intervention1: photon therapy: Proton beam therapy (experimental arm) is superior in functional preservation compared to photon therapy (standard arm) in adults with primary brain tumors receiving foc
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Primary brain tumors 2. Age at irradiation 18 to 70 years 3. Karnofsky Performance Status more than 60 4. Diagnosis histopathological radiological of primary brain tumor with an expected survival of above 5 years 5. Planned for focal cranial radiotherapy 6. Informed consent taken
Exclusion criteria
Exclusion criteria: 1. Reirradiation 2. Palliative radiotherapy 3. Multifocal or multicentric disease 4. Planned for whole brain irradiation or craniospinal irradiation 5. Planned for hypofractionated or stereotactic radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint The 5 year rate of overall survival without functional deterioration functional survival equal to fS will be calculated from the date of randomization. An event concerning the primary endpoint will include Neurocognitive decline CTCAE grade 2 ototoxicity New neuroendocrine axis dysfunction or worsening of pre existing dysfunction Neurological and functional impairment CTCAE gr 3 radionecrosis Disease progression All cause mortalityTimepoint: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: 1. Overall survival & Progression-free survival. 2. Radiation-induced early toxicity. 3. Cumulative incidence of sub-domains of functional survival. 4. Quality of Life (patient-reported outcomes) 5. Post hoc analysis per stratification factorsTimepoint: At the completion of the study | — |
Countries
India
Contacts
Public ContactDr ARCHYA DASGUPTA
Tata Memorial Hospital
Outcome results
None listed