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
17 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
Researchers are investigating the safety and effectiveness of neoadjuvant radiochemotherapy in the surgical treatment of glioblastoma (GBM), a type of brain cancer. This pilot study aims primarily to assess safety, focusing on neurological problems, tissue damage, swelling, headaches, wound healing issues, infections, and cerebrospinal fluid leaks. Secondary goals include evaluating progression-free survival, overall survival, cognitive function using the MoCA scale, and quality of life through various assessment tools. The study involves a small group of patients compared to controls, with a two-year follow-up period and ongoing safety monitoring. Participants in the experimental group will first have a stereotactic biopsy to confirm diagnosis. If diagnosed with wildtype IDH non-mutated glioblastoma, they will receive conformal hypofractionated stereotactic radiotherapy targeting tumor regions in 15 sessions over three weeks, combined with daily temozolomide during radiation. Five weeks after radiation, patients undergo guided surgical tumor removal using 5-ALA with neurophysiological monitoring. Starting four weeks after surgery, maintenance temozolomide chemotherapy is given for six months. The control group follows the standard Stupp protocol involving combined radiotherapy and temozolomide chemotherapy. Participants will have monthly clinical follow-ups for two years, including physical and neurological exams, blood tests, and brain imaging every three to six months to monitor safety outcomes. Cognitive function and quality of life will be assessed quarterly over this period. Researchers will study tissue samples from surgeries for additional biological analysis. The study is randomized without masking and aims to provide detailed safety and efficacy data to inform future treatment approaches.
CONDITIONS
Brief 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 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.
- Hypersensitivity to the active ingredient or any excipients of the investigational drug.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks (15 fractions over 3 weeks)
Participants diagnosed with glioblastoma receive conformal hypofractionated stereotactic radiotherapy with concurrent daily temozolomide during this period.
Daily visits for radiotherapy sessions, 5 days a week
Duration - 1 day
Participants undergo supramarginal tumor resection guided by 5-ALA with intraoperative neurophysiological monitoring.
1 in-person surgical visit
Duration - 6 months
Starting 4 weeks after surgery, participants receive temozolomide chemotherapy for 6 months.
Regular visits for chemotherapy administration and monitoring
Duration - 2 years
Participants are monitored for safety and efficacy outcomes including neurological exams, imaging, cognitive assessments, and quality of life evaluations.
Monthly clinical visits, brain MRI every 3 months, PET scans every 6 months, and cognitive and quality of life assessments every 3 months
Trial Site Locations
Total: 1 location
1
Hospital Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
Research Team
J
Juan Antonio Barcia
M
Mª Rebeca Lliguin León
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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