ISRCTN72785446已完成3 期
A randomised clinical trial evaluating adjuvant chemotherapy with capecitabine compared to expectant treatment alone (observation), following surgical resection of a biliary tract tumour
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 447
研究概览
简要总结
2019 Results article in https://doi.org/10.1016/S1470-2045(18)30915-X (added 13/04/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current information as of 09/02/2010 (update to trial made in December 2008)
- •1. Patients with histologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic/hilar cholangiocarcinoma, muscle invasive gallbladder cancer or cancer of the distal bile duct) who have undergone a macroscopically complete resection with curative intent.
- •2. Eastern Cooperative Oncology Group (ECOG) Performance Status = 2
- •3. Age > 18
- •4. Adequate renal function:
- •4.1. Serum urea and serum creatinine < 1.5 times upper limit of normal (ULN)
- •4.2. Calculated glomerular filtration rate (GFR) using Cockcroft-Gault = 60 ml/min. If the calculated GFR is below 60 ml/min, isotope EDTA confirmation of adequate renal function (as detailed in the Summary of Product Characteristics [SPC] for capecitabine) is required
- •5. Adequate haematological function:
- •5.1. Haemoglobin = 10g/dl
- •5.2. WBC = 3.0 x 109/L
- •5.3. Absolute neutrophil count (ANC) = 1.5 x 109/L
- •5.4. Platelet count = 100,000/mm3
- •6. Adequate liver function:
- •6.1. Total bilirubin = 3 x ULN
- •6.2. Alanine transaminase (ALT) or aspartate transaminase (AST) = 5 x ULN
- •6.3. Adequate surgical biliary drainage with no evidence of infection
- •7. Not of childbearing potential OR must be using an approved method of contraception
- •8. Written informed consent
- •9. Able to start treatment within 12 weeks of surgery. If the treatment start date is >12 weeks, it will be necessary to contact the BILCAP Trial Office.
- •Current information as of 28/02/2008:
- •1. Age 18 or over
- •2. Histologically confirmed biliary tract cancer (including intrahepatic or extrahepatic cholagiocarcinoma or muscle-invasive gallbladder cancer) and undergone macroscopically complete resection with curative intent
- •3. No history of other malignant diseases (other than adequately treated non-melanotic skin cancer or in situ carcinoma of the uterine cervix)
- •4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •5. Adequate renal function (serum urea and serum creatinine less than 1.5 times upper limit of normal [ULN], glomerular filtration rate greater than/equal to 60 ml/min). If the calculated GFR is below 60 ml/min, isotope EDTA confirmation of adequate renal function (as detailed in the Summary of Product Characteristics [SPC] for capecitabine)
- •6. Adequate haematological function (haemoglobin =10 g/dl, white blood cells [WBC] =3.0 x 10^9/l, absolute neutrophil count [ANC] =1.5 x 10^9/l, platelet count =100,000/mm^3)
- •7. Adequate liver function (total bilirubin =3 x ULN, alanine aminotransferase [ALT] or aspartate aminotransferase [AST] =5 times ULN, adequate surgical biliary drainage with no evidence of infection)
- •8. Not of childbearing potential OR must be using an approved method of contraception
- •9. Written informed consent
- •Information at time of registration:
- •1. Age 18 or over
- •2. Histologically confirmed biliary tract cancer (including intrahepatic or extrahepatic cholagiocarcinoma or muscle-invasive gallbladder cancer)
排除标准
- •Current information as of 09/02/2010 (update to trial made in December 2008):
- •1. Pancreatic or ampullary cancer or mucosal gallbladder cancer
- •2. Incomplete recovery from previous surgery or unresolved biliary tree obstruction
- •3. Use of other investigational agents during the study treatment period, or within 4 weeks of planned entry to the study
- •4. History of other malignancy within 5 years of trial entry, except adequately treated cervical carcinoma-in-situ or non-melanotic skin cancer.
- •5. Any previous chemotherapy or radiotherapy, given for biliary tract cancer.
- •6. A serious co-existing medical condition likely to interfere with protocol treatment including a potential serious infection.
- •7. Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
- •Information at time of registration:
- •1. Pancreatic or periampullary cancer or mucosal gallbladder cancer
- •2. Resection of tumour that involved the pancreas
- •3. Incomplete recovery from previous surgery or unresolved biliary tree obstruction
- •4. Use of other investigational agents during the study or within 4 weeks of planned entry to the study
- •5. Previous chemotherapy, radiotherapy, biological or hormone therapy given for biliary tract cancer
- •6. History of second malignancy within 5 years of trial entry, except non-melanotic skin cancer or in situ cervical carcinoma
- •7. A serious co-existing medical condition including a potential serious infection
- •8. Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
- •9. Psychological, familial, sociological or geographical factors considered likely to prevent compliance with the protocol
- •10. Any other serious uncontrolled medical conditions
- •11. Pregnant or breastfeeding women
研究者
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