Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation With Proton Therapy in Pediatric Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vertebral Body-Sparing Craniospinal Proton Irradiation.
- Who it may be relevant to
- Registry conditions: Pediatric Central Nervous System Tumors, Medulloblastoma, Germinoma, Ependymoma. Basic parameters: 4 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation (VBS-CSI) With Proton Therapy in Pediatric Tumors: A Single-Center Prospective Observational Cohort Study
Overview
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.
Interventions
- Radiation 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.
Primary outcome measures
- Incidence of ≥ Grade 3 acute adverse events [Time frame: Up to 3 months after completion of radiotherapy]
Secondary outcome measures (2)
- Active Bone Marrow Preservation Rate [Time frame: Baseline, 3, 6, 12, 24, 36, 48, 60 months]
- Incidence of spinal deformity [Time frame: Baseline and at 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after treatment completion]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07589361 · VBS-CSI-Proton-Pediatric