Reduced Dose Radiotherapy Following High Dose Chemotherapy in Intracranial Non-germinomatous Germ Cell Tumor

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reduced-dose Radiotherapy Following High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Central Nervous System Non-germinomatous Germ Cell Tumors

Conditions
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Intracranial Non-germinomatous Germ Cell Tumor

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Etoposide
* Drug: Cyclophosphamide
* Drug: Bleomycin
* Drug: Thiotepa
* Drug: Melphalan
* Radiation: Reduced dose radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracranial NGGCT<br>Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen. Peripheral blood stem cell collection during the first cycle of chemotherapy. Surgery, if there is residual tumor after chemotherapy. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT) 1st HDCT: Carboplatin, thiotepa, etoposide 2nd HDCT: Cyclophosphamide, melphalan Reduced dose of radiotherapy | Drug: Carboplatin<br> <br> Drug: Etoposide<br> <br> Drug: Cyclophosphamide<br> <br> Drug: Bleomycin<br> <br> Drug: Thiotepa<br> <br> Drug: Melphalan<br> <br> Radiation: Reduced dose radiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of event free survival |  | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of late adverse events |  | Up to 5 years |