Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation With Proton Therapy in Pediatric Tumors (VBS-CSI-PT-PED)
10 mei 2026 bijgewerkt door: JIAYI CHEN, Ruijin Hospital
Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation (VBS-CSI) With Proton Therapy in Pediatric Tumors: A Single-Center Prospective Observational Cohort Study
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Geschat)
38
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Jiayi Chen
- Telefoonnummer: +86 021 64370045
- E-mail: cjy11756@rjh.com.cn
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
This is a prospective observational study enrolling 38 pediatric patients aged >3 years and ≤18 years with histologically confirmed central nervous system tumors requiring craniospinal irradiation (CSI).
Patients will be assigned to 2 cohorts: low-dose CSI and high-dose CSI.
All participants will receive vertebral body-sparing intensity-modulated proton therapy (IMPT) and standard chemotherapy according to clinical guidelines.
Beschrijving
Inclusion Criteria:
- 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.
- Karnofsky Performance Score (KPS) ≥ 80.
- For postoperative patients, complete healing of the surgical incision with no evidence of wound infection or other complications.
- For women of childbearing potential, effective contraception must be used for at least one month prior to screening, and they must commit to continued contraception throughout the study period and for the required time after study completion.
Exclusion Criteria:
- 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.
- Presence of any severe, uncontrolled systemic disease (e.g., active infection, severe cardiac, hepatic, renal, or respiratory insufficiency) that, in the investigator's judgment, makes the subject unsuitable for treatment under this protocol.
- Female patients who are pregnant or breastfeeding.
- Presence of any severe cognitive or psychiatric disorder that prevents understanding of or cooperation with study assessments.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Low-Dose Cohort
Patients in the low-dose cohort receive vertebral body-sparing craniospinal irradiation (VBS-CSI) using pencil-beam scanning proton therapy at a prescription dose of 23.4 Gy(RBE) in 13 fractions or 24 Gy(RBE) in 15 fractions.
|
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.
|
|
High-Dose Cohort
Patients in the high-dose cohort receive vertebral body-sparing craniospinal irradiation (VBS-CSI) using pencil-beam scanning proton therapy at a prescription dose of 36 Gy(RBE) in 20 fractions.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence of ≥ Grade 3 acute adverse events
Tijdsspanne: Up to 3 months after completion of radiotherapy
|
To evaluate the incidence of treatment-related acute adverse events of grade 3 or higher, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
|
Up to 3 months after completion of radiotherapy
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Active Bone Marrow Preservation Rate
Tijdsspanne: Baseline, 3, 6, 12, 24, 36, 48, 60 months
|
The proportion of active bone marrow in the vertebral body is calculated by dividing the width of the low-signal area by the total diameter of the vertebral body, which allows a relatively quantitative assessment of the active bone marrow preservation rate.
|
Baseline, 3, 6, 12, 24, 36, 48, 60 months
|
|
Incidence of spinal deformity
Tijdsspanne: Baseline and at 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after treatment completion
|
Evaluation is performed using whole-neuraxis MRI or whole-spine anteroposterior and lateral X-ray films.
Spinal scoliosis is quantitatively assessed using the Cobb angle measurement method by a radiologist who is blinded to the patient's specific treatment information.
The degree of kyphosis is evaluated by assessing the presence of thoracic kyphosis.
Additionally, vertebral body change characteristics of the thoracolumbar spine are measured, including the posterior-to-anterior ratio (PARs) of the vertebral body-defined as the ratio of the posterior vertebral body height to the anterior vertebral body height-as well as intervertebral disc height.
|
Baseline and at 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after treatment completion
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
30 april 2026
Primaire voltooiing (Geschat)
30 juni 2029
Studie voltooiing (Geschat)
31 december 2033
Studieregistratiedata
Eerst ingediend
29 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
10 mei 2026
Eerst geplaatst (Werkelijk)
15 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
10 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata
- Neoplasmata per histologisch type
- Neoplasmata, glandulair en epitheel
- Glioom
- Neoplasmata, neuro-epitheliaal
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Neuro-ectodermale tumoren, primitief
- Neoplasmata, complex en gemengd
- Ependymoom
- Medulloblastoom
- Rhabdoïde tumor
- Germinoom
Andere studie-ID-nummers
- VBS-CSI-Proton-Pediatric
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .