NCT03110939撤回不适用
A Phase III, Single Center Randomized Controlled Trial of Thoracic Surgery Combined With Intrathoracic Hyperthermic Perfusion for Advanced Lung Cancer / Esophageal Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- local recurrent rate
研究概览
简要总结
The goal of this clinical research study is to explore whether intrathoracic hyperthermic perfusion after radical surgery could reduce local recurrence rate(13%) for advanced lung cancer / esophageal cancer. The safety of intrathoracic hyperthermic perfusion right after surgery.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must not have received any prior anticancer therapy of cancer.
- •expected R0 resection.
- •Histologic diagnosis of squamous cell thoracic esophageal carcinoma of T3-4, any N and any T, N
- •(8th Union for International Cancer Control, Union for International Cancer Control(UICC)-TNM). Histologic diagnosis of non small cell lung cancer, T2-T3, any N. (8th Union for International Cancer Control, UICC-TNM)
- •Age ranges from 18 to 80 years.
- •Without operative contraindication.
- •Eastern Cooperative Oncology Group (ECOG) 0～
- •Signed informed consent document on file.
排除标准
- •Multiple primary cancer.
- •The subject cannot understand and sign the informed consent form(ICF).
- •Patients with concomitant hemorrhagic disease.
- •Any un expected reason for patients can't get operation.
- •Pregnant or breast feeding.
研究组 & 干预措施
hyperthermic perfusion group
Experimental
hyperthermic perfusion 1800-2000ml, normal saline, 45-48℃, 1 hour, speed 300-600ml/min (after standard surgery of advanced lung cancer/esophageal cancer)
干预措施: hyperthermic perfusion (Other)
control group
No Intervention
standard surgery of advanced lung cancer/esophageal cancer
结局指标
主要结局
local recurrent rate
时间窗: 3 years after surgery
recurrent within thoracic cavity
次要结局
- Total complication rate(6 months after surgery)
- mortality rate after treatment(2 months after surgery/intrathoracic hyperthermic perfusion)
- vital signs during treatment(during operation/intrathoracic hyperthermic perfusion)
- The Clavien-Dindo classification(6 months after surgery)
- mortality rate during operation/intrathoracic hyperthermic perfusion(during operation/intrathoracic hyperthermic perfusion)
研究者
Yin Li
vice president of Henan Cancer Hospitan and director of thoracic surgery department
Henan Cancer Hospital
研究点 (1)
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