Neoadjuvant radiochemotherapy for glioblastoma treatment
Official title: Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
Run by Hospital San Carlos, Madrid · NCT06418113 · Data updated 2026-11-12
This study is testing a new combination of radiation and chemotherapy before surgery to see if it helps people with glioblastoma feel better and live longer compared to standard treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Hospital San Carlos, Madrid Academic / other |
| Locations | 1 site (Madrid) |
| Status | Recruiting |
| Started | March 21, 2024 |
| Main results expected | November 21, 2026 |
| Study ends | March 21, 2027 |
| Registry record updated | May 16, 2024 |
| Trial ID | NCT06418113 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with unifocal, unilobar high-grade gliomas eligible for complete surgical resection.
✕Probably not a fit
Patients with multilobar tumors, significant midline shifts, or other contraindications for surgery or treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and efficacy of neoadjuvant radiochemotherapy in patients with glioblastoma prior to surgical resection. Participants will undergo stereotactic biopsy, followed by conformal hypofractionated stereotactic radiotherapy combined with temozolomide, and then a guided surgical resection. The study aims to assess safety outcomes such as neurological deficits and complications, as well as efficacy measures including progression-free survival and quality of life. A control group will receive standard treatment for comparison.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and overall survival for glioblastoma patients.
How similar studies have gone: While this approach is novel, similar studies have shown promise in improving outcomes for glioblastoma patients with neoadjuvant therapies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Hospital Clínico San Carlos
Madrid, Spain Recruiting
Study contacts
- Study coordinator: Juan Antonio Barcia
- Email: jabarcia@ucm.es
- Phone: +34 913303506
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.