drugset / Trial / NCT06418113

Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma

NCT06418113

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-03-21
Primary completion
2026-11-21
Completion
2027-03-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 75 mg/m2