A randomised clinical trial evaluating adjuvant chemotherapy with capecitabine compared to expectant treatment alone following surgery for biliary tract cancer. - BILCAP

The University of Southampton0 个研究点目标入组 360 人开始时间: 2005年8月5日最近更新: 2012年4月24日

适应症

试验速览

暂无简介。

•-Patients with histologically confirmed biliary tract cancer who have undergone a macroscopically complete resection with curative intent
•-Radical surgical approach must have been employed (including liver resection)
•-ECOG performance status less than/equal to 2
•- Adequate renal, haematological and liver function (details specified in protocol)
•- Age 18 years or over
•-No history of other malignant diseases (except non-melantotic skin cancer or in-situ carcimoma of cervix)
•-Women of childbearing potential must not be pregnant and must use adequate contraception during study and for 3 months after the study treatment
•-Written 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

•-Pancreatic or Ampullary cancer
•-Mucosal gallbladder cancer
•-Incomplete recovery from previous surgery or unresolved biliary tree obstruction
•-Use of other investigational agents during the study or within 4 weeks of planned entry into the study.
•-History of second malignancy within 5 years of trial entry, except cervical carcinoma in-situ or non-melanotic skin cancer.
•-Any previous chemotherapy, radiotherapy, biological or hormone therapy given for biliary tract cancer.
•-A serious co-exisiting medical condition inlcuding a potential serious infection.
•-Evidence of significant clinical disorder or laboratory finding which makes it undesirable for the patient to participate in the trial.
•-Any other serious uncontrolled medical conditions
•-Pregnant or breastfeeding women

发起方