Pediatric Central Nervous System TumorsVBS-CSI-PT-PEDNCT07589361
Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation With Proton Therapy in Pediatric Tumors
An observational study of Pediatric Central Nervous System Tumors and Medulloblastoma, run by Ruijin Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Pediatric Central Nervous System Tumors, Medulloblastoma, Germinoma
- What is being tested?
- Vertebral Body-Sparing Craniospinal Proton Irradiation
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to 31 Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Pediatric Central Nervous System Tumors, Medulloblastoma, Germinoma, Ependymoma, Atypical Teratoid/Rhabdoid Tumor (AT/RT)
- Being tested
- Vertebral Body-Sparing Craniospinal Proton Irradiation
- Medical subject headings
- Medulloblastoma, Germinoma, Ependymoma, Rhabdoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertebral Body-Sparing Craniospinal Proton IrradiationRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Vertebral Body-Sparing Craniospinal Proton Irradiation | |
| 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. Receives: Radiation: Vertebral Body-Sparing Craniospinal Proton Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ≥ Grade 3 acute adverse events
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).
Measured: Up to 3 months after completion of radiotherapy
Secondary outcomes (2)
Active Bone Marrow Preservation Rate
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.
Measured: Baseline, 3, 6, 12, 24, 36, 48, 60 months
Incidence of spinal deformity
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.
Measured: Baseline and at 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIAYI CHEN, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589361
- Sponsor's protocol ID
- VBS-CSI-Proton-Pediatric
- Acronym
- VBS-CSI-PT-PED
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07589361
- Acronym / sponsor ID
- VBS-CSI-PT-PED / VBS-CSI-Proton-Pediatric
- Conditions
- Pediatric Central Nervous System Tumors, Medulloblastoma, Germinoma, Ependymoma, Atypical Teratoid/Rhabdoid Tumor (AT/RT)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Cohort | – | Radiation: Vertebral Body-Sparing Craniospinal Proton IrradiationPatients 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. |
| High-Dose Cohort | – | Radiation: Vertebral Body-Sparing Craniospinal Proton IrradiationPatients 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. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vertebral Body-Sparing Craniospinal Proton IrradiationVertebral 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. | Radiation | High-Dose Cohort, Low-Dose Cohort |
Primary outcome
Incidence of ≥ Grade 3 acute adverse events
Time frame: 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).
2 secondary outcomes
Active Bone Marrow Preservation Rate
Time frame: Baseline, 3, 6, 12, 24, 36, 48, 60 months
Incidence of spinal deformity
Time frame: Baseline and at 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Central Nervous System Tumors and Medulloblastoma, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayi Chen (+86 021 64370045, cjy11756@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ≥ Grade 3 acute adverse events (time frame: Up to 3 months after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.