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

NCT07589361 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2026-05-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-06-30
Completion
2033-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07589361 on ClinicalTrials.gov