Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation With Proton Therapy in Ped… (NCT07589361) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation With Proton Therapy in Pediatric Tumors
38 participantsStarted 2026-04-30
Plain-language 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.
Who can participate
Age range
4 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 assessme…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of ≥ Grade 3 acute adverse events
Timeframe: Up to 3 months after completion of radiotherapy