Response Based Treatment for Children With Unresectable Localized Soft Tissue Sarcoma
Phase 2
- Conditions
- Unresectable Localized Soft Tissue Sarcoma
- Interventions
- Registration Number
- NCT02784015
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
To evaluate the treatment outcome of unresectable soft tissue sarcoma using response based treatment
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 41
Inclusion Criteria
- Patients with unresectable localized high grade soft tissue sarcoma
Exclusion Criteria
- Patients with organ dysfunction (ejection fraction, liver function test, creatinine > CTCAE grade 2)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Unresectable localized soft tissue sarcoma Cisplatin 1. Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen. 2. Surgery, if possible 3. Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan) 4. 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 Unresectable localized soft tissue sarcoma Doxorubicin 1. Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen. 2. Surgery, if possible 3. Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan) 4. 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 Unresectable localized soft tissue sarcoma Radiotherapy 1. Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen. 2. Surgery, if possible 3. Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan) 4. 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 Unresectable localized soft tissue sarcoma Etoposide 1. Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen. 2. Surgery, if possible 3. Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan) 4. 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 Unresectable localized soft tissue sarcoma Cyclophosphamide 1. Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen. 2. Surgery, if possible 3. Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan) 4. 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 Unresectable localized soft tissue sarcoma Ifosfamide 1. Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen. 2. Surgery, if possible 3. Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan) 4. 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 Unresectable localized soft tissue sarcoma Carboplatin 1. Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen. 2. Surgery, if possible 3. Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan) 4. 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 Unresectable localized soft tissue sarcoma Melphalan 1. Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen. 2. Surgery, if possible 3. Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan) 4. 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 Unresectable localized soft tissue sarcoma Thiotepa 1. Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen. 2. Surgery, if possible 3. Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan) 4. 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
- Primary Outcome Measures
Name Time Method Rate of event free survival Up to 3 years
- Secondary Outcome Measures
Name Time Method Rate of adverse events Up to 3 years
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of