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Preoperative Proton Irradiation for High-grade Brain Gliomas. (PPrestige)

12 de julio de 2026 actualizado por: Konstantin Gordon, National Medical Research Radiological Centre of the Ministry of Health of Russia

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:

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

9

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Konstantin Gordon, PhD
  • Número de teléfono: 0079105184148
  • Correo electrónico: gordonkb@nmicr.ru

Ubicaciones de estudio

    • Kaluga Oblast
      • Obninsk, Kaluga Oblast, Rusia, 249036
        • Reclutamiento
        • Proton Therapy Department, A. Tsyb Medical Radiological Research Center - branch of the National Medical Radiological Research Center
        • Contacto:
          • Konstantin Gordon, PhD
          • Número de teléfono: 0079105184148
          • Correo electrónico: gordonkb@nmicr.ru

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Patients with radiological signs of single-focal high-grade glioma
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Acute and late radiation-induced toxicity
Periodo de tiempo: 12 months
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical effects
Periodo de tiempo: 12 months
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.
12 months
Maximal dose of preoperative irradiation
Periodo de tiempo: 12 months
To assess the tolerable dose of preoperative radiotherapy based on the irradiation regimen and tumor volume.
12 months
Postoperative safety
Periodo de tiempo: 12 months
To evaluate the safety of postoperative chemoradiotherapy, based on the incidence and severity of early (up to 3 months) and late (>6 months) complications.
12 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Neurosurgical features
Periodo de tiempo: during surgery
To evaluate the specific features of the neurosurgical intervention following preoperative irradiation.
during surgery
Morphological and genetic features
Periodo de tiempo: 12 months
To evaluate the morphological characteristics and molecular-biological profile of the tumor tissue following the surgical treatment phase. Assess circulating tumor DNA at various stages of treatment.
12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Igor Gulidov, A. Tsyb MRRC
  • Investigador principal: Alexey Goryanov, A. Tsyb MRRC

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

31 de diciembre de 2028

Finalización del estudio (Estimado)

31 de diciembre de 2029

Fechas de registro del estudio

Enviado por primera vez

12 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de julio de 2026

Publicado por primera vez (Actual)

17 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 29_06_2026_PPrestige

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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