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NCT Number: NCT03048084

Seizure Treatment in Glioma

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.

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Key information

Conditions

Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Amsterdam UMC, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

Antiepileptic drug levetiracetam

Other names: Keppra

Valproic acid

Drug

Antiepileptic drug valproic acid

Other names: Depakine

Primary outcomes

  1. Ongoing seizure freedom at 6 months

    Time frame: 6 months

    The percentage of patients with ongoing seizure freedom at 6 months

Secondary outcomes

  1. Cumulative incidence of treatment failure for any reason

    Time frame: 36 months

    Cumulative incidence function of time to treatment failure for any reason of ASM treatment using competing risk models with death as a competing event.

  2. Cumulative incidence of treatment failure for specific reasons

    Time frame: 36 months

    Cumulative incidence function of time to treatment failure for specific reasons of ASM treatment using competing risk models with death and non-applicable reasons of failure as competing events. Reasons of failure: uncontrolled seizures, adverse effects, other reasons of treatment failure, and death

  3. Cumulative incidence of a first recurrent seizure

    Time frame: 36 months

    Cumulative incidence function of time to occurrence of a first recurrent seizure after ASM initiation using competing risk models with death as a competing event.

  4. Adverse effects of the treatment

    Time frame: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively

    Severity of adverse effects of the treatment, defined as severity (grade 1-5) of intolerable adverse effects leading to ASM discontinuation according to the Common Terminology Criteria for Adverse- Events (CTCAE) version 5.0

  5. Hospitalisation rate

    Time frame: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively

    hospitalization rate due to treatment failure

  6. Health-related quality of life

    Time frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively

    Health-related quality of life

  7. Cognitive complaints

    Time frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively

    Cognitive complaints using MOS-CFS scores

  8. Mood

    Time frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively

    Anxiety and depression using HADS scale scores

  9. Performance Status

    Time frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively

    Karnofsky Performance Status Score

  10. Epilepsy burden

    Time frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively

    Epilepsy burden

  11. Treatment response

    Time frame: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively

    Treatment response (e.g., maximum dosage of AED, use of add-on AED)

  12. Progression-free survival

    Time frame: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively

    Progression-free survival

  13. Overall survival

    Time frame: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively

    Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Johan AF Koekkoek, MD, PhD

CONTACT

[email protected]

0031715269111

Monique Baas

CONTACT

[email protected]

0031715297012

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Amsterdam UMC, location VUmc
  • Erasmus Medical Center
  • Medical Center Haaglanden

Registry information

Official study title

Seizure Treatment IN Glioma (STING): Comparing a Treatment Strategy With Levetiracetam Versus Treatment With Valproic Acid in Glioma Patients With a First Seizure

Acronym: STING

Important dates

Study start
2018
Primary completion
2028
Study completion
2029
First posted
Feb 9, 2017
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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