Seizure Treatment in Glioma (STING)

  • STATUS
    Recruiting
  • End date
    Jan 1, 2027
  • participants needed
    120
  • sponsor
    Leiden University Medical Center
Updated on 28 February 2022
anticonvulsants
epilepsy
glioblastoma multiforme
astrocytoma
oligodendroglioma
anaplastic astrocytoma
anaplastic oligodendroglioma
antiepileptic
astrocytoma, anaplastic
oligoastrocytoma
anaplastic oligoastrocytoma
levetiracetam
oligodendroglioma, anaplastic

Summary

Currently, treatment with a specific anti-epileptic drug mainly depends on the physicians' preference, as there are no studies supporting the use of one specific anticonvulsant in glioma patients. The overall aim of this randomized controlled trial is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure.

Description

Currently, treatment of glioma patients with a specific anti-epileptic drug (AED) mainly depends on the physicians' preference, as there is no robust evidence from randomized controlled trials supporting the use of one specific anticonvulsant above the other in glioma patients.

Levetiracetam and valproic acid are the most commonly used AEDs in glioma patients. Both drugs are used for the treatment of seizures, have similar toxicity profiles and are non-enzyme inducing AEDs, therefore not interfering with chemotherapeutic drugs. However, it is not known whether one drug is more effective than the other in reducing seizures.

Details
Condition Glioma
Treatment valproic acid, Levetiracetam
Clinical Study IdentifierNCT03048084
SponsorLeiden University Medical Center
Last Modified on28 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically proven or suspected diffuse astrocytoma (Isocytrate Dehydrogenase-1 (IDH-1) wildtype or IDH-1 mutated), diffuse oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), anaplastic astrocytoma (IDH-1 wildtype or IDH-1 mutated), anaplastic oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), glioblastoma (IDH-1 wild-type or IDH-1 mutated), or diffuse astrocytoma not otherwise specified (NOS), anaplastic astrocytoma NOS, oligodendroglioma NOS, oligoastrocytoma NOS, anaplastic oligoastrocytoma NOS, anaplastic oligodendroglioma NOS or glioblastoma NOS
Adult patients: 18 years of age
First epileptic seizure, no longer than 2 weeks ago
Monotherapy with antiepileptic drugs is considered most appropriate at the time of randomization
Willing to provide written informed consent

Exclusion Criteria

Previously treated with antiepileptic drugs, except emergency treatment in the past 2 weeks
History of non-brain tumor related epilepsy
Pregnancy
Presence of contra-indications for use of levetiracetam or valproic acid
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