A dose-finding study of Docetaxel, Oxaliplatin and Capecitabine (TEX) as First-Line Treatment in Patients with Advanced Gastric Cancer - TEX STUDY

AZIENDA OSPEDALIERA DI PARMA0 个研究点目标入组 24 人开始时间: 2009年3月20日最近更新: 2019年1月7日

试验速览

暂无简介。

•· age ≥ 18 years · written informed consent· histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the oesophagus· disease stage: advanced, recurrent or metastatic· uni-dimensionally measurable disease, as assessed by CT and MRI scan in accordance with the RECIST guidelines · prior adjuvant or neoadjuvant treatment for locoregional resectable disease completed at least 3 weeks before study initiation, and could not have included oxaliplatin or docetaxel· radiotherapy ? no prior RT other than adjuvant where relapse is outside the radiotherapy fields · ECOG Performance status 0, 1 or 2· life expectancy > 12 weeks· adequate liver (bilirubin < 2 x ULN, ALT/AST < 2 x ULN), renal (serum creatinine within normal range or glomerular filtration rate of greater than or equal to 60 ml/minute) and bone marrow function (neutrophils > 1500/µl; platelets > 100000/µl, haemoglobin > 9g/dl)
•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

•.prior systemic therapy for advanced or metastatic disease· history of other malignant diseases other than adequately treated non-melanotic skin cancer or in situ carcinoma of the uterine cervix· any medical or psychiatric condition that impairs ability to give informed consent· uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrhythmia?s· clinically significant abnormal ECG or cardiac history (e.g.: patients with myocardial infarction within the last 6 months)· any other serious uncontrolled medical conditions· any pregnant or lactating woman

发起方

AZIENDA OSPEDALIERA DI PARMA