NCT00204646已完成2 期
Phase II Study of Neoadjuvant Dose-Intensive Chemotherapy With Adriamycin and Ifosfamide Followed by High-Dose ICE in Locally Advanced Soft Tissue Sarcomas
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
Complete resection is still the only curative treatment option in patients with soft tissue sarcoma (STS). Patients with a non-resectable STS have a dismal prognosis even without evidence of metastatic disease. The aim of this trial is to determine whether neoadjuvant dose-intensive chemo-radiotherapy is a feasible and effective approach in patients with non-resectable STS.
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
- •Histologically confirmed STS with locally advanced non-resectable disease
- •Metastatic disease is allowed in case of solitary resectable metastases
- •Grading according to Coindre > II°
- •Measurable tumor lesions
- •Age > 18 through 65 years
- •Karnofsky status > 70 %
- •Written informed consent
排除标准
- •Prior chemotherapy
- •Intercurrent disease interfering with the adequate administration of study medication including severe psychological disease
- •Insufficient liver-, renal or bone marrow function
- •Evidence of pregnancy
- •Treatment within another clinical trial
- •Uncontrolled viral Infections (HIV,HBV, HCV)
- •other malignancies
研究者
研究点 (2)
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