Phase IV Study Comparing Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Intravenous Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 361
- 试验地点
- 2
- 主要终点
- Number of complications related to Implantable Venous Access Device
研究概览
简要总结
The aim of this study is to compare the humeral and thoracic implantation of a central venous access by an implantable device in patients with solids tumors who require intravenous chemotherapy. This is a monocentric randomized study. 572 patients will be recruited for 2 years. They will be randomized either in the thoracic implantation, either in the humeral implantation Due to the 1:3 randomization, 143 patients will be randomized in the humeral arm and 429 into the thoracic one. Number of complications related to the implantable device, medico-economic analysis as well as patient satisfaction will be assessed.
Every patients with solid tumor requiring medical device implantation for intravenous chemotherapy treatment will be eligible.
Both humeral and thoracic implantation of medical device are standard procedures. The randomization in a specific arm is the study procedure and is considered as an interventional study in France.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients with solid tumors at an Advanced or metastasis stage requiring placement of implantable catheter for intravenous chemotherapy treatment
- •Older than 18 years
- •Express signed consent
排除标准
- •Life expectancy less than 12 months assessed by investigator
- •Infection or uncontrolled suspected infection
- •Medical contraindication to port implantation by catheter in thoracic or humeral location
- •Pregnant or lactating women
- •Abnormal coagulation
- •Immunosuppressed patients (for example known hepatitis B or C, or known positive Human Immunodeficiency Virus due to the spreading risk)
- •Patient not affiliated to the French social security
- •Access time to the humeral or thoracic port placement higher than 15 days (from the randomization theoretical date)
- •Protected Adult or adult deprived of liberty
结局指标
主要结局
Number of complications related to Implantable Venous Access Device
时间窗: 3 months after medical device placement
Number of complications that will be recorded by medical oncologist
次要结局
未报告次要终点