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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-18
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Vertebral Body-Sparing Craniospinal Proton Irradiation

Treatment groups

38 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators