Definitive radiochemotherapy with 5-FU / cisplatin plus/minuscetuximab in unresectable locally advanced esophageal cancer:a phase II study - LEOPARD II

niversity Hospital Schleswig-Holstein, Campus Luebeck0 个研究点目标入组 78 人开始时间: 2011年5月24日最近更新: 2018年9月10日

适应症

试验速览

暂无简介。

•Signed written informed consent
•Male or female between 18 and 75 years; patients > 75 years if KPS = 80
•Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus, which is not curatively resectable
•Women of child-bearing potential must have a negative pregnancy test
•Adequate cardiac, pulmonary, and ear function
•Adequate bone marrow function: leucocytes > 3.0 x 109/L, neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin > 10.0 g/dL
•Adequate liver function: Bilirubin < 2.0 mg/dL, SGOT, SGPT, AP, ?-GT < 3 x ULN
•Adequate renal function: serum creatinine < 1.5 mg/dL, creatinine clearance > 50 ml/min (calculated value according to Cockroft-Gault equation)
•No known allergy against chimeric antibodies
•Effective contraception for both male and female patients if the risk of conception exists
•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

•Distant metastasis (M1b)
•Previous treatment of esophageal cancer
•Previous exposure to monoclonal antibodies and / or EGFR-targeted therapy
•Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
•Serious concomitant disease or medical condition
•FEV1 < 1,1
•Clinically relevant coronary artery disease or a history of myocardial infarction within the last 12 months or left ventricular ejection fraction (LVEF) below the institutional range of normal
•Any active dermatological condition > Grade 1
•Contraindications to receive cisplatin, 5-FU or cetuximab
•Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
•Pregnancy or lactation
•Known active drug abuse/alcohol abuse
•Social situations limiting the compliance with the study requirements

发起方

niversity Hospital Schleswig-Holstein, Campus Luebeck