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

NCT07589361 | Not Yet Recruiting

• 1 other identifier: VBS-CSI-Proton-Pediatric
• Study Type: observational
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Medulloblastoma; Pediatric Central Nervous System Tumors; Germinoma; Ependymoma; Atypical Teratoid/Rhabdoid Tumor (AT/RT)

Outcome Measures

Primary Outcomes (1)

• Incidence of ≥ Grade 3 acute adverse events

  To evaluate the incidence of treatment-related acute adverse events of grade 3 or higher, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).

  Up to 3 months after completion of radiotherapy

Secondary Outcomes (2)

• Active Bone Marrow Preservation Rate

  Baseline, 3, 6, 12, 24, 36, 48, 60 months

• Incidence of spinal deformity

  Baseline and at 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after treatment completion

Study Arms (2)

Low-Dose Cohort

Patients in the low-dose cohort receive vertebral body-sparing craniospinal irradiation (VBS-CSI) using pencil-beam scanning proton therapy at a prescription dose of 23.4 Gy(RBE) in 13 fractions or 24 Gy(RBE) in 15 fractions.

Radiation: Vertebral Body-Sparing Craniospinal Proton Irradiation

High-Dose Cohort

Patients in the high-dose cohort receive vertebral body-sparing craniospinal irradiation (VBS-CSI) using pencil-beam scanning proton therapy at a prescription dose of 36 Gy(RBE) in 20 fractions.

Radiation: Vertebral Body-Sparing Craniospinal Proton Irradiation

Interventions

Vertebral Body-Sparing Craniospinal Proton Irradiation RADIATION

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.

High-Dose Cohort; Low-Dose Cohort

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective observational study enrolling 38 pediatric patients aged \>3 years and ≤18 years with histologically confirmed central nervous system tumors requiring craniospinal irradiation (CSI). Patients will be assigned to 2 cohorts: low-dose CSI and high-dose CSI. All participants will receive vertebral body-sparing intensity-modulated proton therapy (IMPT) and standard chemotherapy according to clinical guidelines.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Medulloblastoma; Germinoma; Ependymoma; Rhabdoid Tumor

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Complex and Mixed

Central Study Contacts

Jiayi Chen

CONTACT

+86 021 64370045; cjy11756@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Radiation Oncology

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 15, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2033
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share