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Preoperative Proton Irradiation for High-grade Brain Gliomas.

RecruitingPhase 1Ages 18 Years - anyAllNational Medical Research Radiological Centre of …
NCT07710040 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if preopearative proton therapy (PPT) is tolerable in patients with High-grade brain gliomas. It will also learn about the influence on surgical procedure, clinical effects and safety of regular treatment. The main questions it aims to answer are: Does preoprative proton therapy well-tolerated? What maximal dose of PPT is safe? Proposed Treatment Stages 1. Multidisciplinary board (neurosurgeon, radiation therapist, and medical oncologist) decision of patient enrollment. 2. Course of preoperative proton stereotactic radiotherapy (PSRT) directed at the tumor only: GTV=contrast-part of brain giloma, CTV=GTV. Dose regimens: first 3 patients - 4 Gy(RBE) × 5 fractions; subsequent 3 patients - 5 Gy(RBE) × 5 fractions; subsequent 3 patients - 6 Gy(RBE) × 5 fractions. RBE = Relative biological efficacy, equal 1.1 for protons. Should any information

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📋 Eligibility rules (as published)
Inclusion Criteria: * radiologically confirmed (MRI and/or PET with amino-acids) diagnosis of high-grade glioma * single foci * ECOG 0-2 status * tumor location and volume, eligible for gross total resection (GTR) * signed informed consent Exclusion Criteria: * multifocal disease * ECOG 3-4 * inability to achieve GTR
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What it tests

  • Preoperative irradiation
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Where

1 site
Proton Therapy Department, A. Tsyb Medical Radiological Research Center - branch of the National Medical Radiological Research Center
Obninsk, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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