Neoadjuvant radiochemotherapy for glioblastoma treatment
Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
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 |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hospital San Carlos, Madrid Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06418113 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with unifocal, unilobar high-grade gliomas eligible for complete surgical resection.
Not a fit: Patients with multilobar tumors, significant midline shifts, or other contraindications for surgery or treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and overall survival for glioblastoma patients.
How similar studies have performed: While this approach is novel, similar studies have shown promise in improving outcomes for glioblastoma patients with neoadjuvant therapies.
Eligibility criteria
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 this trial is running
Madrid
- Hospital Clínico San Carlos — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Juan Antonio Barcia
- Email: jabarcia@ucm.es
- Phone: +34 913303506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.