Clinical Trial

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

Study acronym: VBS-CSI-PT-PED
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07589361
Lead Sponsor Ruijin Hospital
Conditions Pediatric Central Nervous System Tumors, Medulloblastoma, Germinoma, Ependymoma, Atypical Teratoid/Rhabdoid Tumor (AT/RT)
Enrollment 38 participants
Start Date 2026-04-30
Primary Completion 2029-06-30 (estimated)
Study Completion 2033-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-15