Preoperative Proton Irradiation for High-grade Brain Gliomas.

NCT07710040 | Recruiting Phase 1

• 1 other identifier: 29_06_2026_PPrestige
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Multidisciplinary board (neurosurgeon, radiation therapist, and medical oncologist) decision of patient enrollment.
2. 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 regarding unacceptable treatment toxicity emerge, the study will be terminated.
3. 3.Microsurgical resection of the contrast-enhancing portion of the tumor using fluorescence microscopy and, when indicated, neurophysiological monitoring.
4. 4.Contrast-enhanced MRI to assess the resection volume within the first 24-48 hours after surgery.
5. 5.Follow-up evaluation - clinical, morphological, and radiological assessment of the effects of the preoperative and surgical treatment stages, performed 3-4 weeks after the surgical phase.
6. 6.Standard treatment and follow-up: Chemoradiotherapy with a scanned proton beam combined with temozolomide 75 mg/m², given at 2 Gy × 30 fractions, to commence 4-6 weeks after surgery. Adjuvant chemotherapy with temozolomide 150-200 mg/m² on a 5/23 schedule (maintenance chemotherapy), for 12 cycles or until disease progression/unacceptable toxicity.
7. 7.Follow-up - control examinations every 1 month after completion of chemoradiotherapy, then every 3 months for the first year.

Conditions

High Grade Gliomas

Keywords

high grade gliomas; proton therapy; preoperative irradiation

Outcome Measures

Primary Outcomes (1)

• Acute and late radiation-induced toxicity

  Primary endpoint is to evaluate the safety of preoperative proton stereotactic radiotherapy regimens for HGG based on the incidence and severity of early (up to 3 months) and late (\>6 months) radiation-caused complications.

  12 months

Secondary Outcomes (3)

• Clinical effects

  12 months

• Maximal dose of preoperative irradiation

  12 months

• Postoperative safety

  12 months

Other Outcomes (2)

• Neurosurgical features

  during surgery

• Morphological and genetic features

  12 months

Study Arms (1)

Patients with radiological signs of single-focal high-grade glioma

EXPERIMENTAL

Radiation: Preoperative irradiation

Interventions

Preoperative irradiation RADIATION

After enrollment patientswith radiological signs of HGG will be irradiated by pencil beam protons in the following regimens: 3 pts - 4 GyRBE (RBE = 1.1) x 5 Fx; 3 pts - 5 GyRBE x 5 Fx; 3pts - 6 GyRBE x 5 Fx.

Patients with radiological signs of single-focal high-grade glioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• multifocal disease
• ECOG 3-4
• inability to achieve GTR

Sponsors & Collaborators

• National Medical Research Radiological Centre of the Ministry of Health of Russia: lead

Study Sites (1)

Proton Therapy Department, A. Tsyb Medical Radiological Research Center - branch of the National Medical Radiological Research Center

Obninsk, Kaluga Oblast, 249036, Russia

RECRUITING

Related Publications (19)

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Study Officials

• Igor Gulidov

  A. Tsyb MRRC

  PRINCIPAL INVESTIGATOR

• Alexey Goryanov

  A. Tsyb MRRC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantin Gordon, PhD

CONTACT

0079105184148; gordonkb@nmicr.ru

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leading Researcher

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

RU (1)