Palliative Stenting With or Without Radiotherapy for Inoperable Oesophageal Carcinoma: a Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Relief of dysphagia
研究概览
简要总结
To assess the benefits of oesophageal stenting and external beam radiotherapy over oesophageal stenting alone in patients with inoperable oesophageal cancer
详细描述
A majority of patients with oesophageal cancer present with inoperable disease and require rapid and long lasting palliation of dysphagia.
STUDY AIM: To compare dysphagia relief in patients treated with oesophageal stenting and external beam radiotherapy (EBRT), versus oesophageal stenting alone and to assess overall survival, treatment related complications, and quality of life in the two groups.
PATIENTS AND METHODS: Patients with inoperable oesophageal cancer with high grade dysphagia to be randomised to receive oesophageal stenting alone (Group I), versus a combination of stenting followed by EBRT (Group II). Dysphagia relief, treatment related complications, overall survival, and quality of life to be assessed in the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oesophageal cancer patients with locally advanced unresectable cancer (such as invasion of tracheo-bronchial tree, aorta, pulmonary vascular structures, etc),
- •Metastatic disease, and co-morbid conditions precluding major surgical procedure (such as severe cardiopulmonary, hepatic and renal diseases) with grade 3 and 4 dysphagia, were included in the trial.
排除标准
- •Patients with carcinoma of the cervical oesophagus and those who had already received prior radiotherapy, chemotherapy, or any other modality of treatment were excluded
结局指标
主要结局
Relief of dysphagia
时间窗: 5 months after intervention
Dysphagia grades at 5 months will be assessed in the two groups
次要结局
- Survival(From the date of diagnosis till death)