Perioperative Chemotherapy (FLOT Protocol) Compared To Neoadjuvant Chemoradiation (CROSS Protocol) in Patients With Adenocarcinoma of the Esophagus - ESOPEC

niversitätsklinikum Schleswig-Holstein, Campus Lübeck0 个研究点目标入组 438 人开始时间: 2015年8月3日最近更新: 2022年3月2日

研究概览

暂无简介。

•-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 shold have pulmonary function test with FEV1 >65% of predicted
•-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)
•-given informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•-Tumors of squamous histology
•-Patients with advanced inoperable or metastatic esophageal adenocarcinoma
•-Esophageal adenocarcinoma cT1N0 and cT4b
•-Gastric carcinoma
•-Prior chemotherapy for gastrointestinal cancer,
•-Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 month)
•-Clinically-significant lung disease (FEV1 <65% of predicted
•-Peripheral neuropathy Grade >1

发起方

niversitätsklinikum Schleswig-Holstein, Campus Lübeck