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Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma

Study acronym: GLINERA
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06418113
Lead Sponsor Hospital San Carlos, Madrid
Collaborators: Asociación de Afectados Por Tumores Cerebrales en España (ASATE)
Conditions
(from sponsor)		 Glioblastoma, Glioblastoma Multiforme, Glioblastoma, IDH-wildtype, Radiotherapy; Complications, Cancer Brain
Related terms Brain Neoplasms, Glioblastoma
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov