Clinical trial · Interventional
Vertebral Body Sparing Craniospinal Irradiation for Pediatric Patients With Cancer of the Central Nervous System
Feasibility of Vertebral Body Sparing Intensity Modulated Proton Therapy Craniospinal Irradiation With in Vivo Range Verification in Growing Children
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial studies the feasibility of using intensity modulated proton therapy to deliver craniospinal irradiation while avoiding the bones of the vertebral column. Intensity modulated proton therapy is an advanced radiation therapy modality that uses high energy protons to kill cancer cells and shrink tumors, and may reduce the side effects of treatment by reducing radiation exposure to the spinal column.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Central Nervous System Neoplasm | Malignant Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity-Modulated Proton Therapy | Procedure | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (intensity modulated proton therapy)
- description
- Patients undergo intensity modulated proton therapy once daily over 30 fractions and also undergo MRI over 20 minutes during fractions 7, 13, 20, and 30 of radiation in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Procedure: Intensity-Modulated Proton Therapy
- Procedure: Magnetic Resonance Imaging
Primary outcomes (3)
- measure
- Incidence and severity of acute hematologic toxicity
- timeFrame
- Up to 2 years
- description
- Will be graded according to Common Terminology Criteria for Adverse Events version 5.0.
- measure
- Dose delivered to vertebral bodies and quality assurance of treatment plans
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic diagnosis of central nervous system malignancy requiring craniospinal irradiation. * Signed informed consent and assent when indicated. Exclusion Criteria: * Any contraindication to undergoing MRI (ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial cardiac valves or devices, electrical implants such as cardiac pacemakers or perfusion pumps). Metal fragments, shrapnel, or tattoos near the eye. * Any major uncontrolled or poorly controlled current illness that would limit compliance with study requirements. * Pregnant females are excluded. Females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy.
References
Publications (0)
Data not yet available