NCT02782754Unknown2 期
Treatment of Intracranial Germinoma With Chemotherapy Prior to Reduced Dose and Volume of Radiotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rate of late sequelae
研究概览
简要总结
The purpose of this study is to evaluate the outcome of intracranial germinoma treated with chemotherapy plus reduced radiotherapy.
详细描述
Treatment outcome of intracranial germinoma is excellent with radiotherapy/chemotherapy. However, late sequelae are unavoidable especially with craniospinal irradiation, and various efforts have been done to reduce the dose and extent of radiotherapy. In this study, chemotherapy and further reduced dose of radiotherapy will be used to minimize the late sequelae in the patients with intracranial germinoma.
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 germinoma
排除标准
- •Elevated serum/cerebrospinal fluid alpha-feto protein
- •Patients with organ dysfunction as follows (creatinine elevation, ejection fraction, liver function test > CTCAE grade 2)
研究组 & 干预措施
Intracranial germinoma
Experimental
- Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen
- Reduced dose of radiotherapy
- Without seeding: 18 Gy to ventricle + 12.6 Gy to primary site
- With seeding: craniospinal irradiation 18 Gy + 12.6 Gy to primary site
干预措施: Carboplatin (Drug)
Intracranial germinoma
Experimental
- Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen
- Reduced dose of radiotherapy
- Without seeding: 18 Gy to ventricle + 12.6 Gy to primary site
- With seeding: craniospinal irradiation 18 Gy + 12.6 Gy to primary site
干预措施: Etoposide (Drug)
Intracranial germinoma
Experimental
- Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen
- Reduced dose of radiotherapy
- Without seeding: 18 Gy to ventricle + 12.6 Gy to primary site
- With seeding: craniospinal irradiation 18 Gy + 12.6 Gy to primary site
干预措施: Cyclophosphamide (Drug)
Intracranial germinoma
Experimental
- Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen
- Reduced dose of radiotherapy
- Without seeding: 18 Gy to ventricle + 12.6 Gy to primary site
- With seeding: craniospinal irradiation 18 Gy + 12.6 Gy to primary site
干预措施: Bleomycin (Drug)
Intracranial germinoma
Experimental
- Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen
- Reduced dose of radiotherapy
- Without seeding: 18 Gy to ventricle + 12.6 Gy to primary site
- With seeding: craniospinal irradiation 18 Gy + 12.6 Gy to primary site
干预措施: Reduced dose of radiotherapy (Radiation)
结局指标
主要结局
Rate of late sequelae
时间窗: Up to 5 years
次要结局
- Rate of event free survival(Up to 5 years)
研究者
研究点 (1)
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