NCT00949039已完成3 期
Study Comparing Isolated Pelvic Perfusion With TNF-α 0.3 mg and Melphalan 1.5 mg/kg Versus Standard Treatment in Patients With Non Resectable, Recurrent Gynaecologic or Digestive Pelvic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery).
Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer.
The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated pelvic perfusion.
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 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proved locally advanced gynaecologic or digestive tumours (epidermoid carcinomas, adenocarcinomas, neuroendocrine tumours, sarcomas or melanomas), (cervix, vagina, rectal, anal).
- •Locally recurrent tumours for which surgical treatment will be mutilating or marginal (R1 or R2) and/or for cervix cancer, primary tumours non accessible for standard treatment (radiotherapy- chemotherapy - brachytherapy and surgery).
- •Surgically resectable tumour (R0 type) but for which patient does not agree with surgery.
- •Patients aged over 18 and under 76 ans
- •Performance OMS Index ≤ 2
- •Normal biologic parameters
- •Good general and cardiac state (ASA I or II and NYHA I or II)
排除标准
- •Surgically resectable tumour (RO) or peritoneal tumour extension or distant metastasis.
- •Cardiac or vascular pathology
- •Pulmonary disease
- •Uncontrolled Sepsis disease
- •Pregnancy
研究组 & 干预措施
Chemotherapy
Experimental
Isolated pelvis perfusion
干预措施: Isolated pelvis perfusion (Drug)
Control
Active Comparator
Standard treatment
干预措施: radiotherapy (Radiation)
Control
Active Comparator
Standard treatment
干预措施: Surgery (Procedure)
结局指标
主要结局
Survival rate
时间窗: From randomization to death
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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