Clinical trial · Observational
Study of Neurological Complication After Radiotherapy for High Grade Glioblastoma
EPIBRAINRAD : Study of Neurological Complication After Radiotherapy for Glioblastoma High Grade
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The survival time and the number of long time survivors after radiotherapy in brain cancer patients have increased for the last decades. Therefore the topic of late-delayed neurotoxic effects of this therapy gains more and more importance. Among these side effects, the main and most frequent one is the leukoencephalopathy, a diffused and progressive damage of the white matter characterized by myelin loss, loss of axons and vascular lesions. The incidence rate assessment, as well as the occurrence time, is based on retrospective studies with low numbers of patients, but seems to reach 30 to 50 % of the patients according to the follow-up. The risk seems to be increased during the first two years after the radiotherapy, but persists for decades. To gain further insight in the radiation-induced leukoencephalopathy, the objective of this project is to study the onset and evolution of leukoencephalopathy in a 3-year prospective cohort of patients having undergone cerebral radiotherapy for glioma (stage 3-4), using specific cognitive tests, Magnetic Resonance Imagery (MRI) scans of the brain and predictive bio-markers of cognitive impairments.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukoencephalopathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brain radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- diagnostic procedure
- description
- neurocognitive tests before and after radiotherapy
- interventionNames
- Radiation: brain radiotherapy
Primary outcomes (1)
- measure
- decrease of 1.5 SD of Compurerized Speed Cognitive test
- timeFrame
- before radiotherapy, at 12 and 36 months
Secondary outcomes (4)
- measure
- sensitivity and specificity of the Compurerized Speed Cognitive test
- timeFrame
- at the inclusion time (before radiotherapy), at 12 and 36 months
- description
- comparison of the CSCT result with the results of the complete neurocognitive evaluation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \- diagnosis of glioma (stage 3 to 4) * both genders * age \> 18 years * treatment by radiotherapy and chemotherapy * clinical monitoring post radiotherapy in Neurology Department, Pitié-Salpêtrière University Hospital and in the radiotherapy department of the Paul Strauss Institute. Exclusion Criteria: * \- other neurological tumors and brain metastases * psychiatric severe illness, including severe depression
References
Publications (1)
- DERIVEDDurand T, Jacob S, Lebouil L, Douzane H, Lestaevel P, Rahimian A, Psimaras D, Feuvret L, Leclercq D, Brochet B, Tamarat R, Milliat F, Benderitter M, Vayatis N, Noel G, Hoang-Xuan K, Delattre JY, Ricard D, Bernier MO. EpiBrainRad: an epidemiologic study of the neurotoxicity induced by radiotherapy in high grade glioma patients. BMC Neurol. 2015 Dec 18;15:261. doi: 10.1186/s12883-015-0519-6. PMID 26684198