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A study comparing two anti-epileptic drugs in glioma patients with a first seizure


- candidate number26013
- NTR NumberNTR6735
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jan-2017
- Secondary IDsNL62477.058.17 CCMO
- Public TitleA study comparing two anti-epileptic drugs in glioma patients with a first seizure
- Scientific TitleSeizure Treatment IN Glioma (STING): comparing a treatment strategy with levetiracetam versus treatment with valproic acid in glioma patients with a first seizure
- ACRONYMSTING
- hypothesisThe aim of this study is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure
- Healt Condition(s) or Problem(s) studiedGlioma, Epileptic seizure
- 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
- History of a status epilepticus
- Presence of contra-indications for use of levetiracetam or valproic acid
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2017
- planned closingdate1-sep-2021
- Target number of participants120
- InterventionsTreatment with (A) levetriacetam, or (B) valproic acid
- Primary outcomethe percentage of patients with ongoing seizure freedom at 6 months
- Secondary outcome- time to 6 month seizure freedom
- seizure outcome at 12 months
- level of toxicity and hospitalization rate due to treatment failure
- impact of seizures on HRQoL, cognitive complaints, anxiety/depression and performance status
- burden of epilepsy
- treatment response (e.g., maximum dosage of AED, use of add-on AED).
- progression-free and overall survival
- burden of epilepsy
- treatment response (e.g., maximum dosage of anti-epileptic drug, use of add-on anti-epileptic drug).
- progression-free and overall survival
- TimepointsFollow-up will be maximal 36 months. The timing of outcome assessment will be different for patients with a 3-monthly or 6-monthly follow-up schedule. The first 24 months, patients will be assessed at baseline and subsequently at every follow-up visit. Next, all patients (regardless their follow-up schedule) will be assessed every 6 months.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Linda Dirven
- CONTACT for SCIENTIFIC QUERIESDr. Johan A.F. Koekkoek
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Team Westland
- Publications
- Brief summaryCurrently, treatment with a specific anti-epileptic drug (AED) mainly depends on the physicians� preference, as there are no randomized controlled trials supporting the use of one specific anticonvulsant in glioma patients. The overall aim of this strategy study is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure. In addition, we aim to examine the level of toxicity, the impact of seizures on HRQoL, cognitive complaints, anxiety/depression, performance status and survival.
- Main changes (audit trail)
- RECORD2-jan-2017 - 28-okt-2017


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