Actively Recruiting
Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
Led by Hospital San Carlos, Madrid · Updated on 2024-05-16
12
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
H
Hospital San Carlos, Madrid
Lead Sponsor
A
Asociación de Afectados Por Tumores Cerebrales en España (ASATE)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Unifocal disease
- Unilobar tumor
- Clinical-radiological diagnosis of supratentorial unicentric high-grade glioma, eligible for macroscopically complete resection
You will not qualify if you...
- 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 temozolomide treatment
- Cognitive impairment
- Rejection of informed consent
- Inability to follow up for 2 years
- Women of childbearing potential according to Clinical Trial Facilitation Group criteria
- Hypersensitivity to the active ingredient or any excipients of the investigational drug
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
Research Team
J
Juan Antonio Barcia
CONTACT
M
Mª Rebeca Lliguin León
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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