Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age between 18 and 75 years.

• Unifocal disease.

• Unilobar tumor.

• Clinical-radiological diagnosis of supratentorial unicentric high-grade glioma, eligible for macroscopically complete resection.

Locations
Other Locations
Spain
Hospital Clínico San Carlos
RECRUITING
Madrid
Contact Information
Primary
Juan Antonio Barcia
jabarcia@ucm.es
+34 913303506
Backup
Mª Rebeca Lliguin León
rebeca.lliguin.leon@gmail.com
+34 622059861
Time Frame
Start Date: 2024-03-21
Estimated Completion Date: 2027-03-21
Participants
Target number of participants: 12
Treatments
Experimental: Experimental
Stereotactic biopsy will be performed on patients in the experimental group, who will then be discharged. If the histopathological diagnosis is not wildtype IDH non-mutated glioblastoma, the patient will be withdrawn from the study and receive conventional treatment. If wildtype IDH non-mutated glioblastoma is diagnosed, ten days after the biopsy, patients will undergo conformal hypofractionated stereotactic radiotherapy to the FLAIR hyperintense signal, including the contrast-enhancing tumor on T1, with a total dose of 3990 cGy at the margin in 15 fractions of 266 cGy, one session per day, five days a week, and concurrent temozolomide (TMZ) at 75 mg/m2/day for 7 days/week during the irradiation period (GEINO, 2016). Five weeks later, patients will undergo supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring. Starting from 4 weeks post-surgery, TMZ will be administered for 6 months according to the Stupp protocol.
Other: Stupp Protocol
The Stupp protocol is a standard treatment regimen for glioblastoma, which involves a combination of radiotherapy and chemotherapy.
Sponsors
Collaborators: Asociación de Afectados Por Tumores Cerebrales en España (ASATE)
Leads: Hospital San Carlos, Madrid

This content was sourced from clinicaltrials.gov

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