Seizures During Radiotherapy for High-grade Gliomas

Summary

The primary objective of this trial is to evaluate the seizure frequency during a course of radiotherapy for high-grade (grade III or IV) gliomas. The patients keep a seizure diary during and up to 6 weeks following radiotherapy. Every day, the patients document the number (and type) of seizures and intake of anti-epileptic medication. At the end of radiotherapy, the patients are asked to complete a questionnaire regarding their satisfaction with the seizure diary.

Progression of seizure activity compared to baseline is defined as increase of frequency of seizures by more than 50%, increase of severity of seizures, or as Initiation or increase anti-epileptic medication by at least 25%. To obtain an objective assessment of seizure activity in addition to patient reported outcomes, an electroencephalography (EEG) is performed during the first and the sixth week of radiotherapy, and during the sixth week following radiotherapy.

The main goal of the study is to generate objective data regarding the occurrence, frequency and severity of seizures as well as regarding the use of anti-epileptic medication during the course of radiotherapy for high-grade gliomas. These data are used to evaluate the potential effect of radiotherapy on occurrence of seizures in these patients and generate hypotheses. Therefore, statistical analyses of primary and secondary endpoints focus on descriptive methods. If statistical tests are applied, they are to be interpreted from an exploratory perspective.

Thirty-two patients with documented start of radiotherapy and any documented diary data at baseline and after start of radiotherapy should be subjected to statistical analysis. Assuming that 10% of patients do not fulfil these requirements, a total of 35 patients should be enrolled to this trial. Recruitment should be completed within 12 months.

With this sample size a one-sample binomial test with a one-sided significance level of 2.5% has a power of 80% to yield statistical significance if the rate of patients with progression of seizure events during the course of radiotherapy compared to baseline is 30% (rate under the alternative hypothesis) assuming a 'natural' background progression-rate of 10% without radiotherapy (null hypothesis). If the natural course of the disease would lead to a progression-rate of 5% without radiotherapy only, the power increases to 98%.

Conditions

• High-grade Glioma

Interventions

DIAGNOSTIC_TEST

Seizure Diary

The patients keep a seizure diary during the period of radiotherapy and up to 6 weeks following radiotherapy. Every day, the patients document the number (and type) of seizures and intake of anti-epileptic medication. The seizure diary will be used to assess the rate of patients with progression of seizure events during the course of radiotherapy compared to baseline. To obtain an objective assessment of seizure activity in addition to patient reported outcomes, an electroencephalography (EEG) is performed during the first and the sixth week of radiotherapy, as well as during the sixth week following radiotherapy. Activity typical for epilepsy includes spike waves, sharp waves and/or sharp slow waves and is classified as absent or present.

Sponsors & Collaborators

• Zealand University Hospital

  collaborator OTHER

• University Hospital Schleswig-Holstein

  lead OTHER

Principal Investigators

• Dirk Rades, MD · Department of Radiation Oncology, University of Lübeck, Germany

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2022-04-22

Completion

2022-12-05

Countries

• Germany

Study Locations