A phase II/III randomised trial comparing Epirubicin, Cisplatin and Protracted Venous Infusion (PVI) 5-Fluorouracil (5-FU) (ECF), Epirubicin, Oxaliplatin and PVI 5-FU (EOF), Epirubicin, Cisplatin and Capecitabine (ECX) and Epirubicin, Oxaliplatin and Capecitabine (EOX) in Patients with Advanced Oesophago-Gastric Cancer

The Royal Marsden NHS Foundation Trust (UK)0 个研究点目标入组 1,000 人开始时间: 2002年10月15日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Histologically verified locally advanced or metastatic adenocarcinoma, squamous cell carcinoma or undifferentiated carcinoma of the oesophagus, oesophago-gastric junction, or stomach. Patients with positive resection margin or tumour within 1mm of resection margin are eligible.
•2. Uni-dimensionally measurable disease, as assessed by computed tomography (CT) and magnetic resonance imaging (MRI) scan in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines; evaluable disease, for example on oesophagogastroscopy. The only exception is patients with positive or close resection margins who will be evaluated for survival only.
•3. No prior chemotherapy
•4. No prior radiotherapy other than adjuvant where relapse is outside the radiotherapy fields
•5. A glomerular filtration rate (GFR) of =60 ml/min by EDTA clearance or 24 hour urinary creatinine, investigator?s discretion. Normal serum creatinine.
•6. Serum bilirubin <2 x instiutional upper limit of normal range (IULNR)
•7. Patients should have a projected life expectancy of at least 3 months
•8. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
•9. No history of other malignant diseases other than adequately treated non-melanotic skin cancer or in situ carcinoma of the uterine cervix
•10. Adequate bone marrow function, white blood cell count (WBC) >3 x 10^9/l, neutrophils >1.5 x 10^9/l, platelets >100 x 10^9/l
•11. Written informed consent

•1. Medical or psychiatric condition impairing the ability to give informed consent
•2. Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrhythmias, or clinically significant abnormal electrocardiogram (ECG) or cardiac history having a left ventricular ejection fraction (LVEF) of lower limit of normal range for institution as determined by multiple gated acquisition (MUGA) scan or echocardiogram
•3. Any other serious uncontrolled medical conditions
•4. Any pregnant or lactating woman. Any woman of child bearing potential must have a pregnancy test prior to randomisation and must take adequate precautions to prevent pregnancy during treatment. Any man with a partner of child bearing potential must take adequate precautions to prevent pregnancy during treatment.
•5. Inability to complete the quality of life questionnaire

发起方

The Royal Marsden NHS Foundation Trust (UK)