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High Grade GliomasPhase 1PPrestigeNCT07710040

Preoperative Proton Irradiation for High-grade Brain Gliomas.

A Phase 1 study testing Preoperative irradiation in people with High Grade Gliomas, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
High Grade Gliomas
What is being tested?
Preoperative irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteRussia
Study dates
1 Jul 2026to 31 Dec 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Konstantin Gordon, PhD contact

0079105184148

gordonkb@nmicr.ru

Russia1 site, 1 recruiting

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

    Obninsk, Kaluga Oblast, 249036

    Konstantin Gordon, PhD, 0079105184148, gordonkb@nmicr.ru

    Recruiting

Other trials in Russia

About this study

Official title: Proton PREoperative STereotactic Irradiaiton for High-grade Gliomas (PPrestige): a Single-center Prospective Interventional Pahse 1 Trial

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:

Read more

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 regarding unacceptable treatment toxicity emerge, the study will be terminated.
  3. Microsurgical resection of the contrast-enhancing portion of the tumor using fluorescence microscopy and, when indicated, neurophysiological monitoring.
  4. Contrast-enhanced MRI to assess the resection volume within the first 24-48 hours after surgery.
  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. 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. Follow-up - control examinations every 1 month after completion of chemoradiotherapy, then every 3 months for the first year.
Read the detailed description

High grade gliomas (HGG), especially glioblastomas, are among those disease, for which oncological science doesn't propose any improvements for several decades, since temozolomide became a part of therapy. Preoperative irradiation is a standard of care for various malignant diseases. Historically, for intracranial targets preoperative RT is a taboo. Besides, recent data from preoperative RT of brain metastasis showed promising results and good toxicity profile. We would like to investigate the hypotheses of preoprative proton short-course irradiation can be tolerable and potentially improve outcomes in HGG patients.

High-grade gliomas (astrocytomas CNS WHO grade 3-4, glioblastomas, etc) are the most common primary brain tumors, with an extremely poor survival prognosis and a median overall survival of approximately 15-18 months [1, 2]. Recent advances in drug therapy have, unfortunately, not made a substantial contribution to improving treatment outcomes. Therefore, novel approaches to enhance treatment efficacy are more relevant than ever, and over the past decades, the use of radiotherapy has indeed improved survival in these patients. The standard treatment protocol currently includes maximal safe surgical resection followed by chemoradiotherapy, which is initiated 4-6 weeks after surgery [3]. However, microscopic foci of tumor cells in the postoperative period may proliferate and become manifest even before the start of radiotherapy. A recent meta-analysis showed that 40-50 % of patients with high-grade gliomas experience disease progression already during the interval between surgery and adjuvant treatment [4]. Since complete tumor resection is virtually unattainable, intensification of preoperative treatment may represent an effective option, as it targets the disease at an earlier and potentially more vulnerable stage [5].

There is considerable interest in early treatment strategies for high-grade gliomas that target the pre-, intra-, or early postoperative tumor microenvironment [5]. Preoperative radiotherapy is of particular interest, given the encouraging results observed in many other tumor types; however, it has never been applied to high-grade gliomas before [6, 7, 8, 9]. The preoperative period offers more favorable therapeutic characteristics compared with the postoperative tumor microenvironment, including less tumor hypoxia and molecular heterogeneity, which may consequently enhance the effectiveness of irradiation at this stage [5]. Data from dose-escalation safety studies suggest that a radiation dose additional to the standard postoperative regimen (60 Gy/30 fractions) can be delivered safely, but it remains unclear whether dose escalation can improve patient outcomes [10]. Currently, there are only a limited number of studies on preoperative radiotherapy for high-grade gliomas at various stages of preclinical and clinical investigation [6, 11, 12].

Proton therapy is currently the most sparing modality of radiotherapy, allowing, through its unique dose-distribution characteristics, a significant reduction in exposure to normal tissues-a particularly important consideration when irradiating the brain [13]. The use of proton therapy has been widely established both in primary tumors of the nervous system, including extreme dose escalation in glioblastomas, and in re-irradiation settings [14, 15]. Accumulated clinical experience suggests that the application of protons in the pre- and postoperative setting in patients with high-grade gliomas of the brain may minimize the risks of radiation complications and open up new therapeutic opportunities for this disease.

Being tested
Preoperative irradiation
Keywords
high grade gliomas, proton therapy, preoperative irradiation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative irradiationRadiation

    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.

Study groups in NCT07710040
Study groupRoleWhat they receive
Patients with radiological signs of single-focal high-grade gliomaExperimentalNot described
Receives: Radiation: Preoperative irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (3)

  1. Clinical effects

    To evaluate the clinical effects of postoperative proton beam therapy for HGG based on progression-free survival and overall survival rates during the following intervals: 1) between surgery and chemoradiotherapy and 2) after the chemoradiotherapy phase.

    Measured: 12 months

  2. Maximal dose of preoperative irradiation

    To assess the tolerable dose of preoperative radiotherapy based on the irradiation regimen and tumor volume.

    Measured: 12 months

  3. Postoperative safety

    To evaluate the safety of postoperative chemoradiotherapy, based on the incidence and severity of early (up to 3 months) and late (>6 months) complications.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07710040
Sponsor's protocol ID
29_06_2026_PPrestige
Acronym
PPrestige
Status last verified
Jul 2026
First submitted
12 Jul 2026
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • McClelland S 3rd, Yeboa DN. The Emerging Paradigm of Preoperative Stereotactic Radiosurgery for Resectable Brain Metastases. JAMA Oncol. 2023 Aug 1;9(8):1073-1074. doi: 10.1001/jamaoncol.2023.1342. No abstract available.

    PubMed 37289443

  • Ivy SP, Siu LL, Garrett-Mayer E, Rubinstein L. Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task force of the national cancer institute investigational drug steering committee. Clin Cancer Res. 2010 Mar 15;16(6):1726-36. doi: 10.1158/1078-0432.CCR-09-1961. Epub 2010 Mar 9.

    PubMed 20215542

  • Bisello S, Cilla S, Benini A, Cardano R, Nguyen NP, Deodato F, Macchia G, Buwenge M, Cammelli S, Wondemagegnehu T, Uddin AFMK, Rizzo S, Bazzocchi A, Strigari L, Morganti AG. Dose-Volume Constraints fOr oRganS At risk In Radiotherapy (CORSAIR): An "All-in-One" Multicenter-Multidisciplinary Practical Summary. Curr Oncol. 2022 Sep 27;29(10):7021-7050. doi: 10.3390/curroncol29100552.

    PubMed 36290829

  • Dohopolski M, Schmitt LG, de Vis J, Mostardeiro TR, Anand S, Youssef M, Noch E, Maher E, Sun M, Patel T, Patel A, Barnett S, Lee M, Iakovenko V, Chiu T, Su FC, Pompos A, Lin MH, Cai X, Timmerman R, Dan T, Wardak Z. Comparative Outcomes of Standard Radiation Therapy and 5-Fraction Adaptive Stereotactic Radiation Therapy in Newly Diagnosed Glioblastoma: A Propensity Score-Matched Analysis. Adv Radiat Oncol. 2025 May 18;10(8):101813. doi: 10.1016/j.adro.2025.101813. eCollection 2025 Aug.

    PubMed 40611877

  • Gulidov I, Gordon K, Semenov A, Gogolin D, Lepilina O, Golovanova O, Dujenko S, Medvedeva K, Koryakin S, Ivanov S, Kaprin A. Proton re-irradiation of unresectable recurrent brain gliomas: clinical outcomes and toxicity. J BUON. 2021 May-Jun;26(3):970-976.

    PubMed 34268961

  • Matsuda M, Mizumoto M, Kohzuki H, Sugii N, Sakurai H, Ishikawa E. High-dose proton beam therapy versus conventional fractionated radiation therapy for newly diagnosed glioblastoma: a propensity score matching analysis. Radiat Oncol. 2023 Feb 23;18(1):38. doi: 10.1186/s13014-023-02236-1.

    PubMed 36823671

  • Kiseleva V, Gordon K, Vishnyakova P, Gantsova E, Elchaninov A, Fatkhudinov T. Particle Therapy: Clinical Applications and Biological Effects. Life (Basel). 2022 Dec 9;12(12):2071. doi: 10.3390/life12122071.

    PubMed 36556436

  • Fernandez-Gil BI, Schiapparelli P, Navarro-Garcia de Llano JP, Otamendi-Lopez A, Ulloa-Navas MJ, Michaelides L, Vazquez-Ramos CA, Herchko SM, Murray ME, Cherukuri Y, Asmann YW, Trifiletti DM, Quinones-Hinojosa A. Effects of PreOperative radiotherapy in a preclinical glioblastoma model: a paradigm-shift approach. J Neurooncol. 2024 Sep;169(3):633-646. doi: 10.1007/s11060-024-04765-5. Epub 2024 Jul 22.

    PubMed 39037687

  • Waqar M, Roncaroli F, Djoukhadar I, Akkari L, O'Leary C, Hewitt L, Forte G, Jackson R, Hessen E, Withington L, Beasley W, Richardson J, Golby C, Whitehurst P, Colaco R, Bailey M, Karabatsou K, D'Urso PI, McBain C, Coope DJ, Borst GR. Study protocol: PreOperative Brain Irradiation in Glioblastoma (POBIG) - A phase I trial. Clin Transl Radiat Oncol. 2023 Jan 18;39:100585. doi: 10.1016/j.ctro.2023.100585. eCollection 2023 Mar.

    PubMed 36845633

  • Novikov SN, Gafton GI, Ebert MA, Fedosova EA, Melnik JS, Zinovev GV, Gafton IG, Sinyachkin MS, Kanaev SV. Preoperative stereotactic ablative body radiotherapy with postoperative conventional irradiation of soft tissue sarcomas: Protocol overview with a preliminary safety report. Radiother Oncol. 2021 Aug;161:126-131. doi: 10.1016/j.radonc.2021.05.025. Epub 2021 Jun 2.

    PubMed 34089751

  • 9. V. Gondi, S. Pugh, C. Tsien, T. Chenevert, M. Gilbert, A. Omuro, et al. Radiotherapy (RT) dose-intensification (DI) using intensity-modulated RT (IMRT) versus standard-dose (SD) RT with temozolomide (TMZ) in Newly Diagnosed Glioblastoma (GBM): preliminary results of NRG oncology BN001. Int J Radiat Oncol Biol Phys, 108 (2020), pp. S22-S23, 10.1016/j.ijrobp.2020.07.2109

  • Bonvalot S, Gronchi A, Le Pechoux C, Swallow CJ, Strauss D, Meeus P, van Coevorden F, Stoldt S, Stoeckle E, Rutkowski P, Rastrelli M, Raut CP, Hompes D, De Paoli A, Sangalli C, Honore C, Chung P, Miah A, Blay JY, Fiore M, Stelmes JJ, Dei Tos AP, Baldini EH, Litiere S, Marreaud S, Gelderblom H, Haas RL. Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1366-1377. doi: 10.1016/S1470-2045(20)30446-0. Epub 2020 Sep 14.

    PubMed 32941794

  • Lee G, Strickland MR, Wo JY. Role of Preoperative Radiation Therapy for Resectable Gastric Cancer. J Gastrointest Cancer. 2024 Jun;55(2):584-598. doi: 10.1007/s12029-023-00985-6. Epub 2024 Feb 14.

    PubMed 38353901

  • Lehrer EJ, Ruiz-Garcia H, Nehlsen AD, Sindhu KK, Estrada RS, Borst GR, Sheehan JP, Quinones-Hinojosa A, Trifiletti DM. Preoperative Stereotactic Radiosurgery for Glioblastoma. Biology (Basel). 2022 Jan 26;11(2):194. doi: 10.3390/biology11020194.

    PubMed 35205059

  • Waqar M, Trifiletti DM, McBain C, O'Connor J, Coope DJ, Akkari L, Quinones-Hinojosa A, Borst GR. Early Therapeutic Interventions for Newly Diagnosed Glioblastoma: Rationale and Review of the Literature. Curr Oncol Rep. 2022 Mar;24(3):311-324. doi: 10.1007/s11912-021-01157-0. Epub 2022 Feb 4.

    PubMed 35119629

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Preoperative irradiation in people with High Grade Gliomas, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Konstantin Gordon, PhD (0079105184148, gordonkb@nmicr.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute and late radiation-induced toxicity (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07710040, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

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