Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma

Trial ID: NCT06418113

Interventional - Phase 1 - Recruiting

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.

Conditions

• Glioblastoma
• Glioblastoma Multiforme
• Glioblastoma, IDH-wildtype
• Radiotherapy; Complications
• Cancer Brain

Interventions

• hypofractionated stereotactic radiotherapy
• Stereotactic biopsy
• resection
• Chemotherapy
• radiotherapy Stupp protocol
• Chemotherapy Stupp Protocol

Eligibility

Inclusion criteria

• Age between 18 and 75 years.
• Unifocal disease.
• Unilobar tumor.
• Clinical-radiological diagnosis of supratentorial unicentric high-grade glioma, eligible for macroscopically complete resection.

Exclusion criteria

• Multilobar tumor, interhemispheric or infratentorial extension, or multifocal disease.
• Midline shift greater than 1 cm.
• Intracranial hypertension symptoms requiring corticosteroid treatment.
• Synchronous neoplasia.
• Any contraindication for surgery, radiotherapy, or TMZ treatment.
• Cognitive impairment.
• Rejection of informed consent.
• Inability to follow up for 2 years.
• Women of childbearing potential according to the Clinical Trial Facilitation Group (CTFG) criteria. (https://www.hma.eu/fileadmin/dateien/Human\_Medicines/01-About\_HMA/Working\_Groups/CTFG/2020\_09\_HMA\_CTFG\_Contraception\_guidance\_Version\_1.1.pdf)
• Hypersensitivity to the active ingredient or any excipients of the investigational drug.

Sponsor

Hospital San Carlos, Madrid, Asociación de Afectados Por Tumores Cerebrales en España (ASATE)

Source: ClinicalTrials.gov

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