Medulloblastoma,Germinoma
Conditions
Interventions
treatment group:Vertebral Body-Sparing Craniospinal Proton Radiotherapy
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.The patient's legal guardian voluntarily signs the written informed consent form. 2.Age at diagnosis > 3 years and = 18 years. 3.Histopathologically confirmed diagnosis of a central nervous system (CNS) tumor. 4.Indication for craniospinal irradiation (CSI) confirmed by multidisciplinary team (MDT) discussion. 5.Karnofsky Performance Score (KPS) = 80. 6.For postoperative patients, complete healing of the surgical incision with no evidence of wound infection or other complications. 7.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
Exclusion criteria: 1.Previous receipt of any form of spinal radiotherapy. 2.Previous major spinal surgery for any reason. 3.Presence of clinically significant and confirmed spinal deformity at enrollment (e.g., Cobb angle > 10° measured by MRI or X-ray). 4.Presence of medical contraindications to proton radiotherapy. 5.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. 6.Female patients who are pregnant or breastfeeding. 7.Presence of any severe cognitive or psychiatric disorder that prevents understanding of or cooperation with study assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of grade =3 acute adverse events (according to CTCAE v5.0 criteria); | — |
Secondary
| Measure | Time frame |
|---|---|
| Neurocognitive function;Tumor control ;Incidence of spinal deformity;Completion rate of adjuvant chemotherapy;Quality of life;Active Bone Marrow Preservation Rate;Growth and development status; | — |
Countries
China
Contacts
Public ContactJiayi Chen
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed