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NCT07589361

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

4 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

38

Start Date

2026-04-30

Completion Date

2033-12-31

Last Updated

2026-05-15

Healthy Volunteers

No

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.