Pediatric intracranial germ cell tumor
Conditions
Interventions
Germinoma group:Stratified radiotherapy based on response to induction chemotherapy
NGGCT group:Stratified radiotherapy based on response to induction chemotherapy
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the study and sign the informed consent form; 2. Age 3 to 18 years old, gender not restricted; 3. Primary intracranial germ cell tumors confirmed by histology or clinically diagnosed; 4. Laboratory test results before enrollment are in compliance with: Blood routine: Platelet count >= 100×10^9/L; Absolute neutrophil count >= 1.5×10^9/L or white blood cell count >= 3.0×10^9/L; Hemoglobin >= 90g/L; Blood biochemistry: Aspartate aminotransferase (AST) = 50 points; 6. No previous radiotherapy, chemotherapy, immunotherapy, or targeted therapy; 7. Subjects with reproductive capacity are willing to take contraceptive measures during the study period.
Exclusion criteria
Exclusion criteria: 1. Recurrent intracranial germ cell tumor; 2. Has received any anti-tumor treatment other than surgery and traditional Chinese medicine for germ cell tumors before, including radiotherapy, chemotherapy, targeted drugs, immunotherapy, etc.; 3. Has uncontrollable infections, unmanageable epilepsy and/or hypertension and/or hyperglycemia; 4. Has a history of other malignant tumors; 5. Cannot tolerate radiotherapy; 6. Has other reasons judged by the investigator as being unsuitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year-PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 year-OS;Objective response rate of tumors;adverse effects during radiotherapy and chemotherapy; | — |
Countries
China
Contacts
Public ContactMawei Jiang
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed