Intracranial Non-germinomatous Germ Cell Tumor
Conditions
Brief summary
The purpose of this study is to evaluate the outcome of intracranial non-germinomatous germ cell tumor (NGGCT) treated with reduced radiotherapy following high dose chemotherapy and autologous stem cell transplantation (HDCT/auto-SCT).
Detailed description
Treatment outcome of intracranial NGGCT is around 50% with conventional chemo- and radiotherapy. Also, late sequelae such as endocrinopathy or cognitive problem are unavoidable especially with craniospinal irradiation. In this study, high dose chemotherapy and reduced dose of radiotherapy will be used to improve survival and minimize the late sequelae in the patients with intracranial NGGCT.
Interventions
DRUGCarboplatin
DRUGEtoposide
DRUGCyclophosphamide
DRUGBleomycin
DRUGThiotepa
DRUGMelphalan
RADIATIONReduced dose radiotherapy
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Patients with pathologically proven intracranial non-germinomatous germ cell tumor or * Patients who have brain mass which are suspected as intracranial germ cell tumor and elevated serum or cerebrospinal fluid alpha-feto protein.
Exclusion criteria
* Patients with organ dysfunction (ejection fraction \<40%, creatinine \> 3 x upper limit of normal (ULN), aspartate aminotransferase/alanine aminotransaminase \> 5 x ULN). * Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of event free survival | Up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Rate of late adverse events | Up to 5 years |
Countries
South Korea
Contacts
Primary ContactKi Woong Sung, MD, PhD
Outcome results
None listed