Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation With Proton Therapy in Pediatric Tumors

Официальное название

Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation (VBS-CSI) With Proton Therapy in Pediatric Tumors: A Single-Center Prospective Observational Cohort Study

Обзор

his is a single-center, prospective observational study in children and adolescents with central nervous system tumors who need whole-brain and whole-spine radiation therapy (craniospinal irradiation, CSI). The study uses proton therapy with a special vertebral body-sparing (VBS) technique to protect the front and center of the vertebrae, which helps preserve bone marrow function and growth. The main goals are to find safe dose limits for the vertebrae and check how often severe side effects occur. The study will also look at bone marrow preservation, spinal deformity, tumor control, survival, chemotherapy completion, neurocognitive function, quality of life, and growth and development for up to 5 years after treatment.

Вмешательства

• Лучевая терапия Vertebral Body-Sparing Craniospinal Proton Irradiation
  Vertebral body-sparing craniospinal irradiation (VBS-CSI) using intensity-modulated proton therapy (IMPT, pencil-beam scanning). The treatment actively restricts radiation dose to the anterior and central regions of thoracolumbar vertebral bodies to preserve active bone marrow and spinal growth potential, while ensuring adequate target coverage for the whole brain and spinal cord. Two dose levels are applied: 23.4 Gy(RBE)/13 fractions or 24 Gy(RBE)/15 fractions and 36 Gy(RBE)/20 fractions.

Первичные конечные точки

• Incidence of ≥ Grade 3 acute adverse events [Срок оценки: Up to 3 months after completion of radiotherapy]

Вторичные конечные точки (2)

• Active Bone Marrow Preservation Rate [Срок оценки: Baseline, 3, 6, 12, 24, 36, 48, 60 months]
• Incidence of spinal deformity [Срок оценки: Baseline and at 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after treatment completion]

Критерии участия

Критерии включения

• The patient's legal guardian voluntarily signs the written informed consent form.
• Age at diagnosis > 3 years and ≤ 18 years.
• Histopathologically confirmed diagnosis of a central nervous system (CNS) tumor.
• Indication for craniospinal irradiation (CSI) confirmed by multidisciplinary team (MDT) discussion.
• Karnofsky Performance Score (KPS) ≥ 80.
• For postoperative patients, complete healing of the surgical incision with no evidence of wound infection or other complications.
• For women of childbearing potential, effective contraception must be used for at least one month prior to screening, and they must commit to continued contraception throughout the study period and for the required time after study completion.

Критерии исключения

• Previous receipt of any form of spinal radiotherapy.
• Previous major spinal surgery for any reason.
• Presence of clinically significant and confirmed spinal deformity at enrollment (e.g., Cobb angle > 10° measured by MRI or X-ray).
• Presence of medical contraindications to proton radiotherapy.
• Presence of any severe, uncontrolled systemic disease (e.g., active infection, severe cardiac, hepatic, renal, or respiratory insufficiency) that, in the investigator's judgment, makes the subject unsuitable for treatment under this protocol.
• Female patients who are pregnant or breastfeeding.
• Presence of any severe cognitive or psychiatric disorder that prevents understanding of or cooperation with study assessments.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07589361 · VBS-CSI-Proton-Pediatric

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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