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临床试验/NCT02784054
NCT02784054Unknown2 期

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

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年4月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
25
试验地点
1
主要终点
Rate of event free survival
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 30 Years（Child, Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Intracranial NGGCT

Experimental
  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
  1. Reduced dose of radiotherapy

干预措施: Carboplatin (Drug)

Intracranial NGGCT

Experimental
  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
  1. Reduced dose of radiotherapy

干预措施: Etoposide (Drug)

Intracranial NGGCT

Experimental
  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
  1. Reduced dose of radiotherapy

干预措施: Cyclophosphamide (Drug)

Intracranial NGGCT

Experimental
  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
  1. Reduced dose of radiotherapy

干预措施: Bleomycin (Drug)

Intracranial NGGCT

Experimental
  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
  1. Reduced dose of radiotherapy

干预措施: Thiotepa (Drug)

Intracranial NGGCT

Experimental
  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
  1. Reduced dose of radiotherapy

干预措施: Melphalan (Drug)

Intracranial NGGCT

Experimental
  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
  1. Reduced dose of radiotherapy

干预措施: Reduced dose radiotherapy (Radiation)

结局指标

主要结局

Rate of event free survival

时间窗: Up to 3 years

次要结局

  • Rate of late adverse events(Up to 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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