Phase III Trial Investigating the Potential Benefit of Intensified Peri-operative Chemotherapy With in High-risk CINSARC Patients With Resectable Soft-tissue SARComas
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 351
- 试验地点
- 10
- 主要终点
- Metastasis progression-free survival in High-risk CINSARC patients
研究概览
简要总结
The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).
详细描述
For high-risk CINSARC patients, this is a multicenter randomized two-arm phase III trial, with a ratio 1:1:
- Arm A: standard management (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy)
- Arm B: experimental arm (6 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy)
For low-risk CINSARC patients, this a multicenter prospective cohort with treatment at the discretion of the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
Control-Arm phase III high-risk CINSARC:
Patients will be treated by doxorubicin (60 or 75mg/m² day or 20- or 25 mg/m² per day from day1 to day 3) + ifosfamide (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices of a 21-days cycle for up to 3 cycles in neoadjuvant setting Neoadjuvant chemotherapy will be followed by surgery. If indicated, radiotherapy could be prescribed at the discretion of the investigator (in neoadjuvant or adjuvant setting).
干预措施: Doxorubicin (Drug)
Arm A
Control-Arm phase III high-risk CINSARC:
Patients will be treated by doxorubicin (60 or 75mg/m² day or 20- or 25 mg/m² per day from day1 to day 3) + ifosfamide (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices of a 21-days cycle for up to 3 cycles in neoadjuvant setting Neoadjuvant chemotherapy will be followed by surgery. If indicated, radiotherapy could be prescribed at the discretion of the investigator (in neoadjuvant or adjuvant setting).
干预措施: Ifosfamide or dacarbazine (Drug)
Arm B
Experimental-Arm phase III high-risk CINSARC:
Patients will be treated by doxorubicin (60 or 75mg/m² day or 20 or 25 mg/m² per day from day1 to day 3) + ifosfamide (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices of a 21-days cycle for up to 6 cycles in neoadjuvant setting Neoadjuvant chemotherapy will be followed by surgery. If indicated, radiotherapy could be prescribed at the discretion of the investigator (in neoadjuvant or adjuvant setting).
干预措施: Doxorubicin (Drug)
Arm B
Experimental-Arm phase III high-risk CINSARC:
Patients will be treated by doxorubicin (60 or 75mg/m² day or 20 or 25 mg/m² per day from day1 to day 3) + ifosfamide (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices of a 21-days cycle for up to 6 cycles in neoadjuvant setting Neoadjuvant chemotherapy will be followed by surgery. If indicated, radiotherapy could be prescribed at the discretion of the investigator (in neoadjuvant or adjuvant setting).
干预措施: Ifosfamide or dacarbazine (Drug)
Prospective cohort
Patients will be treated at the discretion of the investigator
干预措施: At the discretion of the investigator (Drug)
结局指标
主要结局
Metastasis progression-free survival in High-risk CINSARC patients
时间窗: 3 years
Metastasis progression-free survival (M-PFS) defined as the time interval between the date of randomization and the date of death or distant progression.
次要结局
- Loco-regional relapse-free survival in High-risk CINSARC patients(3 years)
- Progression-free survival in High-risk CINSARC patients(3 years)
- Overall survival in High-risk CINSARC patients(3 years)
- Best overall response in High-risk CINSARC patients(Throughout the treatment period, an average of 6 months)
- Histological response in High-risk CINSARC patients(An average of 6 months)
- Safety profile in High-risk CINSARC patients(Throughout the treatment period, an average of 6 months)
- Progression-free survival in Low-risk CINSARC patients(3 years)
- Metastasis progression-free survival in Low-risk CINSARC patients(3 years)
- Loco-regional progression-free survival in Low-risk CINSARC patients(3 years)
- Overall survival in Low-risk CINSARC patients(3 years)