Seizure Treatment in Glioma

Glioma Clinical Trial

— STING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03048084
• Other study ID #: 77353
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2018
• Est. completion date: January 1, 2028

Study information

• Verified date: March 2024
• Source: Leiden University Medical Center
• Contact: Johan AF Koekkoek, MD, PhD
• Phone: 0031715269111
• Email: j.a.f.koekkoek[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Seizures

Intervention

Drug:
• Levetiracetam
Antiepileptic drug levetiracetam
• Valproic Acid
Antiepileptic drug valproic acid

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Haaglanden Medical Center	The Hague

Sponsors (4)

Lead Sponsor	Collaborator
Leiden University Medical Center	Amsterdam UMC, location VUmc, Erasmus Medical Center, Medical Center Haaglanden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing seizure freedom at 6 months	The percentage of patients with ongoing seizure freedom at 6 months	6 months
Secondary	Time to 6 months seizure freedom	Time to 6 months seizure freedom	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
Secondary	Seizure outcome at 12 months	Seizure outcome at 12 months	12 months
Secondary	Adverse effects of the treatment	Adverse effects of the treatment	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
Secondary	Hospitalisation rate	hospitalization rate due to treatment failure	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
Secondary	Health-related quality of life	Health-related quality of life	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
Secondary	Cognitive complaints	Cognitive complaints	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
Secondary	Mood	Anxiety and depression	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
Secondary	Performance Status	Karnofsky Performance Status Score	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
Secondary	Epilepsy burden	Epilepsy burden	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
Secondary	Treatment response	Treatment response (e.g., maximum dosage of AED, use of add-on AED)	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
Secondary	Progression-free survival	Progression-free survival	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
Secondary	Overall survival	Overall survival	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