Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Resectability rate
研究概览
简要总结
Carcinoma of the esophagus is the among the most common cancers in Indian population. While adenocarcinoma is more common in western countries, in India squamous cell carcinoma is the more frequent form. Surgery is the standard treatment in resectable lesions, but survival is poor. Adjuvant and neoadjuvant treatment therapy is used with an aim to improve the results. Though few randomized trials have addressed the issue of neoadjuvant chemoradiotherapy, the methodology was inhomogeneous and the populations studied were different. The investigators will be conducting a randomized controlled trial in patients with squamous cell carcinoma of the esophagus. Preoperative chemoradiation followed by surgery will be compared with surgery alone.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 65 years
- •Squamous cell carcinoma
- •Good performance status (Eastern Cooperative Oncology Group [ECOG] grades 0, 1 and 2)
- •Contrast enhanced computerized tomographic (CECT) scan suggesting a potentially resectable lesion. The features of resectability assessed on CECT scan will include - no evidence of infiltration of mediastinal structures such as the aorta (angle of contact <900, no obliteration of the triangular fat space between the esophagus, aorta, and spine), and pericardium20, and no evidence of tracheobronchial fistula or tumor extension into the airway lumen.
- •No evidence of distant metastasis on CECT.
排除标准
- •Patient refused consent for the study
- •Comorbid conditions which would preclude oesophagectomy
- •Poor performance status (ECOG > 2)
- •American Society of Anesthesiologists class IV
- •Metastatic disease detected on evaluation
- •Involvement of mediastinal structures except
- •Carcinoma involving cervical esophagus
- •Previous radiotherapy or chemotherapy
结局指标
主要结局
Resectability rate
时间窗: 2 years
To compare the resectability rate of carcinoma esophagus between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery
postoperative morbidity
时间窗: 2 Years
To compare the postoperative morbidity between patients of carcinoma esophagus randomized to surgery alone versus chemoradiation followed by surgery
operative mortality
时间窗: 2 Years
To compare the operative mortality between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery.
次要结局
- Early disease control(2 years)
- Treatment toxicity(2 years)