Withdrawal of antiepileptic drugs in low grade and anaplastic glioma patients after long-term seizure freedom

Completed

Conditions: 10029211
Epilepsy in brain tumour patients

Registration Number: NL-OMON41523

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

(1) adults (>18 years)
(2) histologically confirmed LGG or anaplastic glioma (WHO grade I pilocytic astrocytoma, pleomorphic xanthoastrocytoma, subependymal giant cell astrocytoma, and subependymoma; WHO grade II astrocytoma , mixed oligo-astrocytoma, oligodendroglioma; ependymoma; WHO grade III brain tumours (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligo-astrocytoma or anaplastic ependymoma))
(3) presence of epilepsy and treatment with AEDs
(4) past anti-tumour treatment (surgical resection, brain irradiation or temozolomide chemotherapy)
(5) stable disease with absence of clinical or radiological signs of tumour recurrence during the past year
(6) seizure freedom for at least 1 year counted from the date of first surgery, last day of first irradiation or last day of first temozolomide chemotherapy cycle; OR seizure freedom for at least 2 years from the last non-acute symptomatic post-therapy seizure.

Exclusion Criteria

Patients who underwent biopsy only.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Study parameters include:<br /><br>- physician*s decision and decision related arguments to continue AEDs despite<br /><br>fulfillment of all in- and exclusion criteria<br /><br>- shared decision on AED continuation or withdrawal and decision related<br /><br>arguments<br /><br>- start date of AED withdrawal, point of complete AED withdrawal, changes in<br /><br>AED type or dose (where applicable)<br /><br>- seizure recurrence<br /><br>- tumour symptoms, additional anti-tumour treatment and tumour recurrence<br /><br>- treatment related adverse effects.</p><br>

Secondary Outcome Measures