Health Condition 1: C719- Malignant neoplasm of brain, unspecified
Conditions
Interventions
Intervention1: Levetiracetam: In the experimental arm, Levetiracetam will be tapered by 250- 500 mg every week and stopped.
Control Intervention1: Levetiracetam: In the standard arm, patients will con
Sponsors
Tata Memorial Centre Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: History of seizure Histological diagnosis of primary brain tumor Supratentorial location of primary tumor Controlled on levetiracetam monotherapy for 6 months Index surgery within 1 year Karnofsky Performance Scale (KPS) â?¥ 50 Imaging within the previous 6 months demonstrating radiologically stable disease status and clinical stability during screening.
Exclusion criteria
Exclusion criteria: Include the cumulative incidence of seizures impacting awareness 2-year seizure-free survival in each stratum. Quality of life assessment Cost-benefit analysis Progression-free survival Overall survival Post hoc analysis per histological category for seizure control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year seizure-free survival for both the arms. Date of seizure relapse after randomization will be considered as an event.Timepoint: 2 year after accrual of last patient. Considering the expected period of enrolment being 5 years, and another 2 years for follow-up, the primary outcome will be evaluated at 7 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survivalTimepoint: 7 year;Progression-free survivalTimepoint: 7 year;Quality of lifeTimepoint: 7 year | — |
Countries
India
Contacts
Public ContactDr Archya Dasgupta
Tata Memorial Centre Mumbai
Outcome results
None listed