Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
Hospital San Carlos, Madrid
12 participants
Mar 21, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria10
- 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.
Interventions
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
supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring
4 weeks post-surgery, temozolomide (TMZ) will be administered for 6 months
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.
temozolomide (TMZ) will be administered for 6 months according to the Stupp protocol.
Locations(1)
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NCT06418113