A Phase II Study Evaluating Neo-/Adjuvant EIA Chemotherapy, Surgical Resection and Radiotherapy in High-risk Soft Tissue Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide, ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. An additional 4 cycles of adjuvant chemotherapy is administered. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.
详细描述
The role of chemotherapy in high-risk soft tissue sarcoma is controversial. Though many patients undergo initial curative resection, distant metastasis is a frequent event resulting in 5-year overall survival rates of only 50 - 60%. Neo-adjuvant and adjuvant chemotherapy has been applied to achieve pre-operative cytoreduction, assess chemosensitivity and to eliminate occult metastasis. The current protocol comprises for cycles of neoadjuvant chemotherapy ((EIA, etoposide 125 mg/m2 iv days 1 and 4, ifosfamide 1500 mg/m2 iv days 1 - 4, doxorubicin 50 mg/m2 day 1, pegfilgrastim 6 mg sc day 5), local surgery and radiotherapy as well as further 4 cycles of adjuvant EIA. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Soft tissue sarcoma histology
- •Tumor size >= 5 cm
- •Deep/extracompartimental localization
- •Grade 2/3 (FNCLCC)
- •Patients with inadequate previous therapy
- •Age 18-65 years
- •normal bone marrow function
- •normal liver function
- •normal renal function
- •Karnofsky index >=80%
排除标准
- •Chondrosarcoma
- •Kaposi´ sarcoma
- •Neuroblastoma
- •Mesothelioma
- •Osteosarcoma/Ewings´sarcoma
研究组 & 干预措施
Treatment Arm
All patients receive 4 cycles of EIA chemotherapy pre- and postoperatively. There is no further observation arm. The study is non-randomized.
干预措施: EIA chemotherapy (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 2 years after study completion
Disease-free survival will be calculated from the time of definite surgery to radiologically proven local or distant failure or patient´s death due to sarcoma related cause.
次要结局
- Overall Survival(2 years after study completion)
- Grade of histological necrosis(After definite surgery, approx. 12-15 weeks after study inclusion)
- Hematological toxicity(Once weekly for an average of 8 months)
- Renal Toxicity(Once weekly for an average of 8 months)
- Liver Toxicity(Once weekly for an average of 8 months)
- Correlation of Tumor Necrosis and Decline in PET SUV(After tumor resection, approx. 12-15 weeks after study inclusion)
- Cardiac Toxicity(Every 6 weeks for an average of 8 months)
- Radiologic Tumor Response(Every 6 weeks for an average of 8 months, then every 3 months for 2 years)