eoadjuvant chemoradiotherapy vs. chemotherapy alone in locally advanced esophageal squamous cell carcinoma: randomized phase II study

Seoul National University Hospital0 个研究点目标入组 114 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

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•1) Histologically diagnosed esophageal squamous cell carcinoma (T1N1,2 or T2-4aN1-2, excluding T1N0 & T2N0) (RECIST1.1 can participate without measurable lesion)
•2) esophageal cancer with previously not treated with surgery , chemotherapy , or radiation therapy
•3) Over 20 years old, under 75 years old
•4) ECOG performance status 0, 1
•5) Appropriate bone marrow, liver, new function
•- Bone marrow function: absolute neutrophil count (ANC) = 1.5 x 109 / L, platelet count = 100 x 109 / L, - hemoglobin = 10 g / dL
•- liver function: total bilirubin = 1.5 x upper normal limit, AST, ALT = 2.5 x Upper nomal limit, alkaline phosphatase = 2.5 x upper normal limit
•- renal function: serum creatinine = 1.5 x upper normal limit
•6) Appropriate lung function
•- FEV1 (1 second forced expiratory volume)> 50% predicted value, DLCO(Diffusion lung capacity for carbon monoxide)> 50% predicted value
•7) agree to participate in clinical trials and obtained written consent

•1) distant metastasis (M1 stage)
•2) cervical esophageal cancer difficult to radical surgery (within18 cm from incisor) or gastric esophageal cancer (<2 cm from cardia) 3) Subject with a history of other malignant diseases within the last 3 years (allowed cured skin basal cell carcinoma, cervical intraepithelial cancer, early gastric cancer) 4) Active infection requiring antibiotic treatment 5) received chemotherapy 30 days 6) radiation therapy for chest or mediastinum in past 7) significant and ascites surgery 8) Pregnant lactating women 9) Subjects receiving organ transplants immunosuppressive 10) peripheral neuropathy NCI CTCAE v.4.0 grade 2 higher 11) clinically cardiopulmonary disease (eg, congestive heart failure, symptomatic coronary artery disease, myocardial infarction 6 months, arrhythmia uncontrolled, moderate to severe COPD, etc.) 12) vascular stenosis 13) who are not appropriate researchers>

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