CTRI/2013/09/003981招募中未知
Preoperative chemoradiation and surgery versus surgery alone in gastroesophageal junction adenocarcinoma of oesophagus â??A Randomized controlled trial
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Age < 70 years
- •2.Adenocarcinoma
- •3.Good performance status (Eastern Cooperative Oncology Group [ECOG] grades 0, 1 and 2) i.e the patient should not be spending more than 50% of his time in Bed.
- •4.Swallowing capacity at preop or preop neoadjuvant is a minimum of oral intake (liquid or semisolid)
- •5.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 pericardium, and no evidence of tracheobronchial fistula or tumor extension into the airway lumen.
- •6.No evidence of distant metastasis on CECT of neck , thorax and abdomen.
排除标准
- •1.Patient refuses consent for the study
- •2.Co-morbid conditions which would preclude oesophagectomy
- •a.Poor performance status (ECOG > 2)
- •b.American Society of Anesthesiologists class IV
- •3.Metastatic disease detected on evaluation
- •4.Involvement of mediastinal structures as described in the inclusion criteria
- •5.Carcinoma involving upper third of the esophagus.
- •6.Previous radiotherapy or chemotherapy
研究者
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