NCT06418113 Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
| NCT ID | NCT06418113 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hospital San Carlos, Madrid |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-03-21 |
| Primary Completion | 2026-11-21 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-03-21 with a primary completion date of 2026-11-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06418113 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06418113 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06418113 currently recruiting?
Yes, NCT06418113 is actively recruiting participants. Contact the research team at jabarcia@ucm.es for enrollment information.
Where is the NCT06418113 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06418113 clinical trial?
NCT06418113 is sponsored by Hospital San Carlos, Madrid. The trial plans to enroll 12 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.