Health Condition 1: G938- Other specified disorders of brain
Conditions
Interventions
Intervention1: Proton beam therapy: Patients in the test arm (proton beam therapy) will receive CSI plus TB boost to appropriate cobalt gray dose equivalent (CGE) on a modern proton gantry using image
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of primary CNS tumor planned for craniospinal irradiation. Curative-intent CSI with or without systemic chemotherapy. Age at irradiation: more than 5 years to 39 years. Fair performance status (LPS/KPS): greater equal to 60. Written informed consent/assent.
Exclusion criteria
Exclusion criteria: Reirradiation Palliative intent radiation On concurrent medications likely to impact neurocognitive outcomes Inability to undergo neurocognitive evaluation pre-radiation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Qualified Overall Survival (QOS)Timepoint: 2 yrs | — |
Secondary
| Measure | Time frame |
|---|---|
| Neuro-cognitive outcome: FSIQ, Verbal comprehension, Perceptual Reasoning Neuro-endocrine outcomes: Hormonal profile Visual outcomes: Drop in acuity or new-onset field defects Hearing outcomes: Chang-Brock scale Symptomatic radiation necrosis (requiring bevacizumab) Patterns of failure/relapse Vasculopathy including cerebrovascular accidents (CVA) Second malignant neoplasm (SMN)Timepoint: Baseline,6 months post RT,1yr,2yr,3yr,4yr,5yr;5-year progression-free survival (PFS) 5-year overall survival (OS) 5-year QOSTimepoint: 5 years | — |
Countries
India
Contacts
Public ContactDr Tejpal Gupta
Tata Memorial Centre
Outcome results
None listed