CTRI/2013/03/003497招募中2 期
Phase II randomized trial comparing neoadjuvant chemotherapy and neoadjuvant chemoradiotherapy for locoregionally advanced esophageal cancer
Tata MemorialHospital0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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.Patients with biopsy or cytology proven squamous esophageal cancer
- •2.Patients with staging investigations indicating locoregionally advanced disease ? T3,4 with N0/1 tumors (by CT and/or EUS, wherever possible)
- •3.Surgical plan for total transthoracic esophagectomy
- •4.American Society of Anesthesiologists (ASA) grade I, II
- •5.Nutrition SGA A or B
- •6.Normal hematological and biochemical parameters
排除标准
- •1.Patients with localized, early esophageal cancer (T1,2, N0/1 tumors)
- •2.Patients with tumors grossly infiltrating the aorta or tracheo bronchial tree
- •3.Patients with distant metastases (supraclavicular and celiac node metastases will not be considered as distant metastases)
- •4.Patients with low performance status (ECOG score > 1)
- •5.Patients with extensive pulmonary tuberculosis
- •6.Patients previously treated with esophageal stenting
- •7.Patients with pre existing renal disease precluding administration of chemotherapy
- •8.Patients who have received previous chemotherapy or radiotherapy for the disease
- •9.Patients with previous history of malignancy
- •10.Patients unfit for surgical resection
- •11.Patients below 18 years and above 70 years of age.
研究者
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