intracranial germ cell tumors
Conditions
Interventions
gross-total resection:gross-total resection
near-total resection:near-total resection
experimental group:Chemotherapy combined with radiotherapy
Sponsors
Huashan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
3 Years to 24 Years
Inclusion criteria
Inclusion criteria: Project 1 1. Patient aged 3 to 24 years at the time of enrollment; 2. Newly diagnosed patients; 2.1. Eligible histological diagnosis; 2.1.1 Immature teratoma; 2.1.2 Teratoma with malignant transformation; 2.2.3 Endodermal sinus tumor (yolk sac tumor); 2.2.4 Choriocarcinoma; 2.2.5 Embryonal carcinoma; 2.1.6 Mixed germ cell tumor; 2.2 Histological unconfirmed pineal and/or suprasellar tumors with serum and/or CSF tumor markers of beta HCG>50 IU/L or any elevation of alpha fetoprotein >10 IU/L; 3. Localized disease, without metastatic disease by cranial or spinal MRI evaluation or CSF cytology. Project 2: 1. Patient aged 3 to 24 years at the time of enrollment; 2. Newly diagnosed patients (no histological confirmation required): germ cell tumors located in the suprasellar, pineal, bifocal (pineal + suprasellar) , ventricles and outside the ventricles (basal ganglia, thalamus) are eligible; normal AFP in both serum and CSF (unless medically contraindicated) AND hCG? <=50 mIU/ml in both serum and CSF (unless medically contraindicated); 3. Newly diagnosed patients with histologically confirmed germinoma or germinoma mixed with mature teratoma and normal AFP in both serum and CSF (unless medically contraindicated) AND hCG <=50 mIU/ml in both serum and CSF (unless medically contraindicated).
Exclusion criteria
Exclusion criteria: Project 1: 1. Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids; 2. Patients doesnt have adequate organ function, and a life expectancy of < 8 weeks. Project 2: 1. Mature teratoma with normal markers; 2. Patients with metastatic disease by cranial or spinal MRI evaluation or CSF cytology (unless medically contraindicated) are not eligible; 3. Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids; 4. Patient doesnt have adequate organ function, and a life expectancy of < 8 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhang Rong
Huashan Hospital Fudan University
Outcome results
None listed