RecruitingPhase 1NCT06418113

Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma


Sponsor

Hospital San Carlos, Madrid

Enrollment

12 participants

Start Date

Mar 21, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety of giving radiation therapy and chemotherapy before surgery (neoadjuvant treatment) for glioblastoma — the most aggressive type of brain tumor. By treating the tumor before removing it, researchers hope to make surgery more effective and improve outcomes. **You may be eligible if...** - You are between 18 and 75 years old - You have a single brain tumor (glioblastoma) confined to one area of one side of the brain (supratentorial, unifocal, unilobar) - Your tumor appears completely removable based on imaging **You may NOT be eligible if...** - Your tumor involves multiple brain regions, crosses to the other side of the brain, or affects the brain stem or cerebellum - Your tumor has caused a midline shift greater than 1 cm (a dangerous shift of brain structures) - You are experiencing symptoms of dangerously high brain pressure requiring steroid treatment - You have another active cancer - You have any condition that prevents you from having surgery, radiotherapy, or chemotherapy with temozolomide - You have significant cognitive impairment - You are a woman of childbearing potential (per specific CTFG criteria) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONhypofractionated stereotactic radiotherapy

conformal hypofractionated stereotactic radiotherapy to the FLAIR hyperintense signal, including the contrast-enhancing tumor on T1, with a total dose of 3990 cGy at the margin in 15 fractions of 266 cGy, one session per day, five days a week, and concurrent temozolomide (TMZ) at 75 mg/m2/day for 7 days/week during the irradiation period

PROCEDUREStereotactic biopsy

Stereotactic biopsy

PROCEDUREresection

supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring

DRUGChemotherapy

4 weeks post-surgery, temozolomide (TMZ) will be administered for 6 months

RADIATIONradiotherapy Stupp protocol

radiotherapy + TMZ concurrently after 4 weeks of resection surgery, as per usual protocol: Three-dimensional radiotherapy planning to deliver a total dose of 60 Gy, with a fractionation of 2 Gy/day, 5 days/week, encompassing a 1-2 cm margin around the contrast-enhancing region defined on T1 imaging or the entire abnormal volume defined on T2 or FLAIR imaging (Li et al., 2016) + TMZ at 75 mg/m2/day for 7 days/week, for 6 weeks during radiotherapy.

DRUGChemotherapy Stupp Protocol

temozolomide (TMZ) will be administered for 6 months according to the Stupp protocol.


Locations(1)

Hospital Clínico San Carlos

Madrid, Spain

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NCT06418113


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