Randomized 1. Line treatment with gemcitabine, capecitabine, oxaliplatin vs gemcitabin and cisplatin to patients with cholangiocarcinoma.

Herlev University Hospital0 个研究点目标入组 100 人开始时间: 2014年4月4日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•Informed consent
•Age > 18 years
•Performance status 0-1
•Patient with histological cholangiocarcinoma or malign cells and a CT-scan in accordance to a cholangiocarcinoma.
•The disease not suitable for surgery
•Neutrofile granulocytes ? 1.5 x 109/l and thrombocytes ? 75 x 109/l
•Bilirubine ? 2.0 x UNL (upper normal limit).
•Creatinine-clearence ? 45 ml/min
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•Other current or prior malignant disease in the past five years, except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
•The patient is not allowed to participate in other clinical trials with antineoplastic treatment..
•Other severe medical conditions
•Presence of diseases preventing oral therapy
•Patients with uncontrolled infection
•Pregnant or lactating women
•Women capable of childbearing not using a sufficient method of birth control
•Patients not able to understand the treatment or to collaborate
•Known prior hypersensitivity reactions to the agents

发起方

Herlev University Hospital