NCT02784015Unknown2 期
Response-based Treatment for Children With Unresectable Localized Soft Tissue Sarcomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Rate of event free survival
研究概览
简要总结
To evaluate the treatment outcome of unresectable soft tissue sarcoma using response based treatment
详细描述
Response after initial chemotherapy is one of the important prognostic factor in many cancers. In this study, treatment will be tailored according to the treatment responses which are assessed by tumor volume reduction, necrosis rate or residual fludeoxyglucose (FDG) uptake in positron emission tomography (PET) scan.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unresectable localized high grade soft tissue sarcoma
排除标准
- •Patients with organ dysfunction (ejection fraction, liver function test, creatinine > CTCAE grade 2)
研究组 & 干预措施
Unresectable localized soft tissue sarcoma
Experimental
- Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen.
- Surgery, if possible
- Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan)
- Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation, if there are still residual tumors after 9 cycle of chemotherapy, surgery, and radiotherapy.
- 1st HDCT: carboplatin, thiotepa, etoposide
- 2nd HDCT: cyclophosphamide, melphalan
干预措施: Cisplatin (Drug)
Unresectable localized soft tissue sarcoma
Experimental
- Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen.
- Surgery, if possible
- Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan)
- Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation, if there are still residual tumors after 9 cycle of chemotherapy, surgery, and radiotherapy.
- 1st HDCT: carboplatin, thiotepa, etoposide
- 2nd HDCT: cyclophosphamide, melphalan
干预措施: Etoposide (Drug)
Unresectable localized soft tissue sarcoma
Experimental
- Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen.
- Surgery, if possible
- Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan)
- Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation, if there are still residual tumors after 9 cycle of chemotherapy, surgery, and radiotherapy.
- 1st HDCT: carboplatin, thiotepa, etoposide
- 2nd HDCT: cyclophosphamide, melphalan
干预措施: Doxorubicin (Drug)
Unresectable localized soft tissue sarcoma
Experimental
- Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen.
- Surgery, if possible
- Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan)
- Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation, if there are still residual tumors after 9 cycle of chemotherapy, surgery, and radiotherapy.
- 1st HDCT: carboplatin, thiotepa, etoposide
- 2nd HDCT: cyclophosphamide, melphalan
干预措施: Cyclophosphamide (Drug)
Unresectable localized soft tissue sarcoma
Experimental
- Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen.
- Surgery, if possible
- Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan)
- Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation, if there are still residual tumors after 9 cycle of chemotherapy, surgery, and radiotherapy.
- 1st HDCT: carboplatin, thiotepa, etoposide
- 2nd HDCT: cyclophosphamide, melphalan
干预措施: Ifosfamide (Drug)
Unresectable localized soft tissue sarcoma
Experimental
- Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen.
- Surgery, if possible
- Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan)
- Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation, if there are still residual tumors after 9 cycle of chemotherapy, surgery, and radiotherapy.
- 1st HDCT: carboplatin, thiotepa, etoposide
- 2nd HDCT: cyclophosphamide, melphalan
干预措施: Carboplatin (Drug)
Unresectable localized soft tissue sarcoma
Experimental
- Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen.
- Surgery, if possible
- Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan)
- Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation, if there are still residual tumors after 9 cycle of chemotherapy, surgery, and radiotherapy.
- 1st HDCT: carboplatin, thiotepa, etoposide
- 2nd HDCT: cyclophosphamide, melphalan
干预措施: Radiotherapy (Radiation)
Unresectable localized soft tissue sarcoma
Experimental
- Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen.
- Surgery, if possible
- Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan)
- Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation, if there are still residual tumors after 9 cycle of chemotherapy, surgery, and radiotherapy.
- 1st HDCT: carboplatin, thiotepa, etoposide
- 2nd HDCT: cyclophosphamide, melphalan
干预措施: Thiotepa (Drug)
Unresectable localized soft tissue sarcoma
Experimental
- Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen.
- Surgery, if possible
- Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan)
- Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation, if there are still residual tumors after 9 cycle of chemotherapy, surgery, and radiotherapy.
- 1st HDCT: carboplatin, thiotepa, etoposide
- 2nd HDCT: cyclophosphamide, melphalan
干预措施: Melphalan (Drug)
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 adverse events(Up to 3 years)
研究者
研究点 (1)
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