Seizures During Radiotherapy for High-grade Gliomas

NCT04552756 | Terminated

• 1 other identifier: SURF-ROGG
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Seizures

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Increased Seizure Activity

  Seizure activity will be assessed using the patient's seizure diary.

  6 - 6.5 weeks (during the radiotherapy course)

Study Arms (1)

Patients irradiated for high-grade glioma

EXPERIMENTAL

Participants who receive radiotherapy or radiochemotherapy for glioblastoma (grade IV), anaplastic astrocytoma (grade III) or anaplastic oligodendroglioma (grade III).

Diagnostic Test: Seizure Diary

Interventions

Seizure Diary DIAGNOSTIC_TEST

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.

Patients irradiated for high-grade glioma

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven grade III or IV glioma
• Indication for normo-fractionated radiotherapy
• Age ≥18 years
• Written informed consent
• Capacity of the patient to contract

You may not qualify if:

• Pregnancy, Lactation
• Expected Non-Compliance (patient unable to use the seizure diary)

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• Zealand University Hospital: collaborator

Study Sites (1)

Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein, Ratzeburger Allee 160, 23562 Lübeck, Germany

Lübeck, 23562, Germany

Location

Related Publications (1)

• Rades D, Witteler J, Olbrich D, Trillenberg P, Schild SE, Tvilsted S, Kjaer TW. A prospective interventional study evaluating seizure activity during a radiotherapy course for high-grade gliomas (SURF-ROGG). BMC Cancer. 2021 Apr 9;21(1):386. doi: 10.1186/s12885-021-08121-y.

  PMID: 33836671 DERIVED

MeSH Terms

Conditions

Glioma; Seizures

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirk Rades, MD

  Department of Radiation Oncology, University of Lübeck, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 17, 2020
• Study Start: March 1, 2021
• Primary Completion: April 22, 2022
• Study Completion: December 5, 2022
• Last Updated: January 15, 2025

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)