Short Versus Long-term Levetiracetam in Brain Tumors
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTata Memorial Centre
About this trial
Levetiracetam is the commonly preferred anti-seizure medicine in patients with brain tumors. This drug has reduced the risk of seizure events occurring but is associated with a risk of side effects such as increased headache, drowsiness, loss of muscle coordination, and psychological challenges in patients. In patients undergoing appropriate treatment for brain tumors and controlled of seizures in the initial few months of levetiracetam, the chance of further seizures is relatively low. The optimal duration to give levetiracetam is not well defined for these patients, and currently as standard treatment levetiracetam is continued for 2-3 years. This study aims to answer this question by comparing patients on a short course of levetiracetam (experimental arm) versus a longer course of levetiracetam (standard arm), with the anticipation that a shorter duration of treatment will not lead to increased seizure episodes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
History of seizure
Histological diagnosis of primary brain tumor
Supratentorial location of primary tumor
Controlled on levetiracetam monotherapy for 6 months
Disqualifiers
KPS < 50
No history of seizure
Unclear history of seizure episodes in the past
Use of antiepileptics other than levetiracetam in the previous 6 months
Trial design
Design model
Parallel
Treatments tested in this trial
Levetiracetam
DrugLevetiracetam is usually preferred in brain tumor-related epilepsy. Levetiracetam is a second-generation antiepileptic drug that binds to synaptic vesicle glycoprotein SV2A, which interferes with the release of neurotransmitters from the synaptic vesicle and control seizure by multiple mechanisms.
Treatment groups
604 Participants
are divided into 2 treatment groupsGroup A: STANDARDOther 1 intervention
Group B: EXPERIMENTALExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2-year seizure free survival
Seizure-free survival measured using Kaplan-Meier product limit method survival calculated from the time of randomization.
Time frame
7 yearSecondary outcomes
1
Overall survival
Overall survival calculated using Kaplan-Meier product-limit method. Death from any cause will be considered as an event.
Time frame
7 year2
Progression-free survival
Progression-free survival calculated using Kaplan-Meier product-limit method. Date of radiological progression will be considered as an event.
Time frame
7 year3
Cost-benefit analysis Cost-benefit analysis
Cumulative cost of antiepileptic medications and cost of management of seizures between the two groups will be compared using proportions of expenditure.
Time frame
7 year4
Quality of life core questionnaire
The European Organization for Research and Treatment of Cancer (EORTC) quality of life (QOL) core questionnaire (C30) will be used. The summary scores will be calculated from the raw scores as per the manual, ranging from 0 to 100, with higher scores representing better outcomes. The global score and scores of subdomains will be calculated during follow-up and compared with baseline.
Time frame
7 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tata Memorial Centre
Lead sponsor
Manipal Academy for Higher Education
Collaborator
Source ClinicalTrials.gov