Central Nervous System Germ Cell Tumor
Conditions
Interventions
Germinoma stratum
Arm A1:
1)Chemotherapy: 4 cycles alternating CE regimen (carboplatin 560 mg/m2 day1, etoposide 150 mg/m2 day1-3) and PE regimen (cisplatin 90 mg/m2 day1, etoposide 150 mg/m2 day1-3)
Sponsors
ARAKAWA Yoshiki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Registration criteria 1) Diagnosed as newly diagnosed central nervous system germ cell tumor in pathological diagnosis, or clinically proven diagnosis of central nervous system germ cell tumor. 2) Registered in the observational study for pediatric solid tumors by Japan Children's Oncology Group (JCCG). 3) Any age 4) No prior chemotherapy or head radiation therapy for any intracranial tumors. 5) Written informed consent is obtained from the patient or his/her legal guardian. Germinoma stratum 1) Diagnosed as germinoma in pathological diagnosis. 2) 3 years or older, less than 30 years. 3) Serum alpha-fetoprotein (AFP)=2000/microliter and neutrophil >=1000/microliter 2. PLT>=100,000/microliter 3. AST=250 ng/mL or HCG >=500mIU/ml. 2) 3 years or older, less than 30 years. 3) No multiple tumors. 4) No dissemination. 5) Protocol treatment can be started within 6 weeks after surgery or cllinial diagnosis. 6) ECOG performance status (PS) of 0, 1, 2, or 3 due to neurological signs caused by the tumor. 7) The following conditions are met within 14 days prior to registration 1. WBC>=2000/microliter and neutrophil >=1000/microliter 2. PLT>=100,000/microliter 3. AST<=100IU/L 4. D-Bil<=1.0mg/dl 5. Serum creatinine level is below the upper limit of normal value Prospective observation stratum 1) Diagnosed pathologically or clinically diagnosed as germ cell tumor except for germinoma stratum and malignant germ cell tumor stratum 2) At any age 3) Regardless of tumor location, number, and dissemination
Exclusion criteria
Exclusion criteria: Germinoma stratum and malignant germ cell tumor stratum 1) Active double cancer (synchronous double cancer and metachronous double cancer with disease-free period of 5 years or less). 2) Complicated with extracranial metastasis. 3) Complicated heart disease requiring treatment. 4) Pregnant or nursing. Prospective observation stratum 1) Judgement of inappropriate inclusion by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year progression free survival rate (5-year PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year overall survival rate (5 year OS) Overall response rate (CR+PR rate) Proportion of 5-year Quality of Life (QOL) preservation Proportion of 5-year cognitive funcition preservation Proportion of adverse events | — |
Contacts
Public ContactYoshiki ARAKAWA
Kyoto University Hospital
Outcome results
None listed