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

Sponsor

Samsung Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT02784054

Collaborator

(none)

Enrollment

Location

Arm

107

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Intracranial Non-germinomatous Germ Cell Tumor	Drug: Carboplatin Drug: Etoposide Drug: Cyclophosphamide Drug: Bleomycin Drug: Thiotepa Drug: Melphalan Radiation: Reduced dose radiotherapy	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2014

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intracranial NGGCT 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 Drug: Etoposide Drug: Cyclophosphamide Drug: Bleomycin Drug: Thiotepa Drug: Melphalan Radiation: Reduced dose radiotherapy

Arm

Intervention/Treatment

Experimental: Intracranial NGGCT

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

Drug: Etoposide

Drug: Cyclophosphamide

Drug: Bleomycin

Drug: Thiotepa

Drug: Melphalan

Radiation: Reduced dose radiotherapy

Outcome Measures

Primary Outcome Measures

Rate of event free survival [Up to 3 years]

Secondary Outcome Measures

Rate of late adverse events [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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