NCT06418113RecruitingPhase 1
Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
Source: ClinicalTrials.gov · Last updated 16 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 3 Apr 2024
- Start date
- 21 Mar 2024
- Primary completion date
- 21 Nov 2026
- Lead sponsor
- Hospital San Carlos, Madrid
- Diseases
- Glioblastoma
- NCT number
- NCT06418113
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From 21 Mar 2024 to the primary completion date, 21 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any contraindication for surgery, radiotherapy, or TMZ treatment.
- Hypersensitivity to the active ingredient or any excipients of the investigational drug.
Other illness
- Multilobar tumor, interhemispheric or infratentorial extension, or multifocal disease.
- Intracranial hypertension symptoms requiring corticosteroid treatment.
- Cognitive impairment.
Other
- 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)
Who the study is looking for
- Age between 18 and 75 years.
- Unifocal disease.
- Unilobar tumor.
- Clinical-radiological diagnosis of supratentorial unicentric high-grade glioma, eligible for macroscopically complete resection.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.