Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation (VBS-CSI) With Proton Therapy in Pediatric Tumors: A Single-Center Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 38
- 主要终点
- Incidence of ≥ Grade 3 acute adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) ≥
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Vertebral Body-Sparing Craniospinal Proton Irradiation (Radiation)
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.
干预措施: Vertebral Body-Sparing Craniospinal Proton Irradiation (Radiation)
结局指标
主要结局
Incidence of ≥ Grade 3 acute adverse events
时间窗: 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).
次要结局
- Active Bone Marrow Preservation Rate(Baseline, 3, 6, 12, 24, 36, 48, 60 months)
- Incidence of spinal deformity(Baseline and at 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after treatment completion)
研究者
JIAYI CHEN
Director, Department of Radiation Oncology
Ruijin Hospital