DRKS00008008已完成3 期
Perioperative Chemotherapy (FLOT Protocol) Compared To Neoadjuvant Chemoradiation (CROSS Protocol) in Patients With Adenocarcinoma of the Esophagus - ESOPEC
niversity Hospital Schleswig-Holstein0 个研究点目标入组 438 人开始时间: 2015年9月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 438
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •- Histologically verified adenocarcinoma of the esophagus according to the UICC definition (TNM7)
- •- Pre-treatment stage cT1N+, M0 or cT2-4a, N0/+, M0
- •- Age =18 years
- •- No prior abdominal or thoracic radiotherapy
- •- ECOG Performance status 0-2
- •- Adequate cardiac function ( Patients with a cardiac history (e.g. myocardial
- •infarction, heart failure, coronary artery disease) should have a cardiology review)
- •- Adequate bone marrow function (WBC>3x10^9/l; Hb>9g/dl; platelets >100x10^9/l)
- •- Adequate respiratory function. Symptomatic Patients should have pulmonary function tests with FEV1>1,5l )
- •- Adequate renal function (GFR >60ml/min)
- •- Adequate liver function (serum bilirubin <1.5x Upper level of Normal (ULN); AST <2.5x ULN and ALT <3x ULN (ULN as per institutional standard)
- •- written informed consent
排除标准
- •Exclusion Criteria:
- •- Tumors of squamous or other non-adenocarcinoma histology
- •- Patients with advanced inoperable or metastatic esophageal adenocarcinoma
- •- Stage cT1N0 and cT4b
- •- Gastric carcinoma
- •- Prior chemotherapy for cancer,
- •- Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months)
- •- Clinical significant lung disease (FEV 1<1,5l)
- •- Peripheral neuropathy Grade >1
研究者
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