Preoperative Proton Therapy for High-Grade Brain Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 study investigates the safety and tolerability of a short course of preoperative proton stereotactic radiotherapy directed at the tumor. Patients receive escalating doses (4 Gy(RBE)×5, then 5 Gy(RBE)×5, then 6 Gy(RBE)×5) with proton therapy prior to surgical resection. The study monitors surgical outcomes, short-term safety, and treatment-related effects to determine the maximal tolerable dose. Enrollment requires a radiologically confirmed high-grade glioma eligible for gross total resection, with preserved performance status. The trial is conducted at a single proton therapy center in Obninsk, Russia, sponsored by the National Medical Research Radiological Centre.

Why it matters

Who can join: the full rules

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

Where it's running

• Proton Therapy Department, A. Tsyb Medical Radiological Research Center - branch of the National Medical Radiological Research Center
  Obninsk, Kaluga Oblast, Russia Recruiting

Study contacts

• Principal investigator: Igor Gulidov — A. Tsyb MRRC
• Study coordinator: Konstantin Gordon, PhD
• Email: gordonkb@nmicr.ru
• Phone: 0079105184148

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.