The goal of this clinical trial is to evaluate the safety and efficacy of neoadjuvant radiochemotherapy in the surgical resection of glioblastoma (GBM). The main questions it aims to answer are:
* What is the safety profile of neoadjuvant radiochemotherapy in terms of neurological deficit, radionecrosis, edema, headache, wound dehiscence, infection, and cerebrospinal fluid fistula? * What is the efficacy of neoadjuvant radiochemotherapy in terms of progression-free survival, overall survival, cognitive function, and quality of life?
Participants will undergo the following tasks and treatments:
* Stereotactic biopsy and diagnosis confirmation. * Conformal hypofractionated stereotactic radiotherapy with concurrent temozolomide. * Supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring. * Maintenance temozolomide administration for 6 months.
Researchers will compare the group receiving neoadjuvant radiochemotherapy to the control group following the standard Stupp protocol to assess safety and efficacy outcomes.
Age between 18 and 75 years.
Unifocal disease.
Unilobar tumor.
Clinical-radiological diagnosis of supratentorial unicentric high-grade glioma, eligible for macroscopically complete resection.
Multilobar tumor, interhemispheric or infratentorial extension, or multifocal disease.
Midline shift greater than 1 cm.
Intracranial hypertension symptoms requiring corticosteroid treatment.
Synchronous neoplasia.
Hospital San Carlos, Madrid
Lead sponsor
Asociación de Afectados Por Tumores Cerebrales en España (ASATE)
Collaborator