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

Phase 2

• Conditions: Intracranial Non-germinomatous Germ Cell Tumor
• Interventions: Drug: Carboplatin; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Bleomycin; Drug: Thiotepa; Drug: Melphalan; Radiation: Reduced dose radiotherapy

• Registration Number: NCT02784054
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-26
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-19
• Primary Completion: 2021-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intracranial NGGCT	Reduced dose radiotherapy	1. Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen. 2. Peripheral blood stem cell collection during the first cycle of chemotherapy. 3. Surgery, if there is residual tumor after chemotherapy. 4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT) * 1st HDCT: Carboplatin, thiotepa, etoposide * 2nd HDCT: Cyclophosphamide, melphalan 5. Reduced dose of radiotherapy
Intracranial NGGCT	Etoposide	1. Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen. 2. Peripheral blood stem cell collection during the first cycle of chemotherapy. 3. Surgery, if there is residual tumor after chemotherapy. 4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT) * 1st HDCT: Carboplatin, thiotepa, etoposide * 2nd HDCT: Cyclophosphamide, melphalan 5. Reduced dose of radiotherapy
Intracranial NGGCT	Carboplatin	1. Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen. 2. Peripheral blood stem cell collection during the first cycle of chemotherapy. 3. Surgery, if there is residual tumor after chemotherapy. 4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT) * 1st HDCT: Carboplatin, thiotepa, etoposide * 2nd HDCT: Cyclophosphamide, melphalan 5. Reduced dose of radiotherapy
Intracranial NGGCT	Cyclophosphamide	1. Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen. 2. Peripheral blood stem cell collection during the first cycle of chemotherapy. 3. Surgery, if there is residual tumor after chemotherapy. 4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT) * 1st HDCT: Carboplatin, thiotepa, etoposide * 2nd HDCT: Cyclophosphamide, melphalan 5. Reduced dose of radiotherapy
Intracranial NGGCT	Bleomycin	1. Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen. 2. Peripheral blood stem cell collection during the first cycle of chemotherapy. 3. Surgery, if there is residual tumor after chemotherapy. 4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT) * 1st HDCT: Carboplatin, thiotepa, etoposide * 2nd HDCT: Cyclophosphamide, melphalan 5. Reduced dose of radiotherapy
Intracranial NGGCT	Thiotepa	1. Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen. 2. Peripheral blood stem cell collection during the first cycle of chemotherapy. 3. Surgery, if there is residual tumor after chemotherapy. 4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT) * 1st HDCT: Carboplatin, thiotepa, etoposide * 2nd HDCT: Cyclophosphamide, melphalan 5. Reduced dose of radiotherapy
Intracranial NGGCT	Melphalan	1. Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen. 2. Peripheral blood stem cell collection during the first cycle of chemotherapy. 3. Surgery, if there is residual tumor after chemotherapy. 4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT) * 1st HDCT: Carboplatin, thiotepa, etoposide * 2nd HDCT: Cyclophosphamide, melphalan 5. Reduced dose of radiotherapy

Primary Outcome Measures

Name	Time	Method
Rate of event free survival	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
Rate of late adverse events	Up to 5 years

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of