Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma

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.

Interventions

• hypofractionated stereotactic radiotherapy · RADIATION

  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

• Stereotactic biopsy · PROCEDURE

  Stereotactic biopsy

• resection · PROCEDURE

  supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring

• Chemotherapy · DRUG

  4 weeks post-surgery, temozolomide (TMZ) will be administered for 6 months

• radiotherapy Stupp protocol · RADIATION

  radiotherapy + TMZ concurrently after 4 weeks of resection surgery, as per usual protocol: Three-dimensional radiotherapy planning to deliver a total dose of 60 Gy, with a fractionation of 2 Gy/day, 5 days/week, encompassing a 1-2 cm margin around the contrast-enhancing region defined on T1 imaging or the entire abnormal volume defined on T2 or FLAIR imaging (Li et al., 2016) + TMZ at 75 mg/m2/day for 7 days/week, for 6 weeks during radiotherapy.

• Chemotherapy Stupp Protocol · DRUG

  temozolomide (TMZ) will be administered for 6 months according to the Stupp protocol.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (1)

• Hospital Clínico San Carlos, Madrid, Spain · RECRUITING