Seizure Treatment IN Glioma (STING): comparing a treatment strategy with levetiracetam versus treatment with valproic acid in glioma patients with a first seizure

Phase 4

Recruiting

Conditions: glioma
Primary brain tumor
10029211

Registration Number: NL-OMON50617

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 120

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 4 weeks ago. Also patients with a
glioma, who have had tumor-related epilepsy in the past, can be included if
they have been seizure-free for >=2 years without the use AEDs
- Monotherapy with antiepileptic drugs is considered most appropriate at the
time of randomization
- Willing to provide written informed consent

Exclusion Criteria

- Treated with antiepileptic drugs for the past 2 years, except emergency
treatment in the past 4 weeks
- History of non-brain tumor related epilepsy
- Pregnancy
- Presence of contra-indications for use of levetiracetam or valproic acid

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The percentage of patients with ongoing seizure freedom at 6 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> - Time to 6 month seizure freedom<br /><br>- Seizure outcome at 12 months, according to the ILAE outcome classification<br /><br>scale<br /><br>- Level of toxicity and hospitalization rate due to treatment failure<br /><br>- HRQoL, anxiety/depression, cognitive complaints, and performance status<br /><br>- Burden of epilepsy<br /><br>- Treatment response (e.g., maximum dosage of AED, use of add-on AED)<br /><br>- Progression-free and overall survival </p><br>