NCT00551577Unknown2 期
Prospective, Randomized Phase II Clinical Trial to Select Primary Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer Stage FIGO IIIC and IV
University Hospital, Bonn4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2003年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Preoperative reduction of ascites volume
研究概览
简要总结
The purpose of this study is to evaluate response to neoadjuvant chemotherapy by imaging and observation of anatomical and biological indicators (i.e. ascites or continuous measurement of tumor marker CA 125). Furthermore the optimal number of preoperative administered cycles of combination chemotherapy with carboplatin and docetaxel should be determined.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •histological confirmed ovarian neoplasm
- •Figo stage IIIC (2cm extrapelvic disease) or Figo IV
- •more than 500 ml ascites volume (measured by sonography)
- •age > 18 years old
- •ECOG <= 2
- •adequate hepatological, renal and haematological function
- •informed consent
排除标准
- •concomitant or previous malignant diseases
- •debulking procedures on initial surgical approach
- •existing peripheral sensoric neuropathy >= grade 2
- •acute infections
- •mental disorders, cerebral metastasis
- •bowel obstruction
结局指标
主要结局
Preoperative reduction of ascites volume
时间窗: preoperative: after 2nd or 3rd cycle of chemotherapy (3-weekly course)
次要结局
- Evaluation of overall response, Evaluation of postoperative tumor size, Evaluation of perioperative morbidity and mortality, QOL(6 months)
研究者
研究点 (4)
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