Palliative stenting with radiotherapy versus stenting with chemoradiotherapy for inoperable oesophageal carcinoma : a randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- i)To compare relief of dysphagia and quality of life (QOL) in patients with inoperable oesophageal cancer treated with stenting followed by radiotherapy versus those treated with stenting followed by chemoradiotherapy
研究概览
简要总结
. Chemoradiotherapy combined with oesophaÂgeal stenting could improve the symptoms of dysphagia in patients with inoperÂable oesophageal carcinoma and could prolong their survival as well. Some case control studies have shown that stenting with chemoradiotherapy prolonged survival and effectively improved symptoms of dysphagia than stenting alone in patients with inoperable advanced oesophageal cancer. To date, there are no published randomised studies examining relief of dysphagia and Health-related quality of life (HRQoL) in patients with advanced oesophageal carcinoma treated with SEMS placement and chemoradiotherapy. This randomised trial aims to evaluate the potential efficacy of SEMS implantation and chemoradiotherapy in inoperable oesophageal carcinoma over stenting with radiotherapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •i)Oesophageal and gastro oesophageal junction cancer patients with •Locally advanced unresectable cancer such as invasion of tracheobronchial tree, aorta, pulmonary vascular structures. •Metastatic disease. •Comorbid conditions or general health status precluding a major surgical procedure with grade III and IV dysphagia. •Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale ii)Vocal cord palsy. iii)Dysphagia grades 3 and
- •iv)Biopsy proven carcinoma.
- •both squamous cell and adenocarcinoma.
排除标准
- •i) Carcinoma of cervical oesophagus ii) Patients who had already received prior radiation or chemo radiotherapy or any other modality of treatment.
- •iii) Patients unstable for endoscopic procedure and for radiotherapy/chemoradiotherapy due to severe co-morbid illness such as congestive heart failure, severe hepatic and renal failure.
结局指标
主要结局
i)To compare relief of dysphagia and quality of life (QOL) in patients with inoperable oesophageal cancer treated with stenting followed by radiotherapy versus those treated with stenting followed by chemoradiotherapy
时间窗: to measure QOL every two months till death
次要结局
- i)To assess overall survival (OS) benefit of chemoradiotherapy following stenting versus radiotherapy following stenting in these patients.(ii)To assess treatment related complications between the two treated groups)