Tests radiation and chemotherapy before surgery in adults with brain tumor glioblastoma
Tests radiation and chemotherapy before surgery in adults with glioblastoma, a brain cancer.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
Key facts
- Where
- Madrid, SpainSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06418113, who can take part
Where in Spain
- Hospital Clínico San CarlosMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital San Carlos, Madrid
- Trial code
- NCT06418113
- Record updated
- 16 May 2024
- Original description
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:Read full original descriptionShow less
Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
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.
Inclusion: 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: Any contraindication for surgery, radiotherapy, or TMZ treatment; Hypersensitivity to the active ingredient or any excipients of the investigational drug; Multilobar tumor, interhemispheric or infratentorial extension, or multifocal disease; Intracranial hypertension symptoms requiring corticosteroid treatment; Cognitive impairment; Midline shift greater than 1 cm; Synchronous neoplasia; 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).