A randomised phase II trial of weekly high-dose 5-fluorouracil with and without folinic acid and cisplatin in patients with advanced biliary tract carcinoma: results of the 40955 EORTC trial

A randomised phase II trial of weekly high-dose 5-fluorouracil with and without folinic acid and cisplatin in patients with advanced biliary tract carcinoma: results of the 40955 EORTC trial
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DOI:
10.1016/j.ejca.2004.10.026
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发表时间:
2005-02-01
影响因子:
8.4
通讯作者:
Nordlinger, B
Nordlinger, B
中科院分区:
医学1区
文献类型:
--
作者:
Ducreux, M;van Cutsem, E;Nordlinger, B

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先前的小型II期试验已经证明,5-氟尿嘧啶(5 FU)和顺铂(CDDP)的组合可以在转移性胆道癌中具有临床活性。这项随机II期试验旨在评估高剂量每周输注5 FU单药(HDFU)和5 FU、亚叶酸(FA)和CDDP联合给药的活性和安全性。如果患者有组织学证实的局部晚期或转移性胆道癌,世界卫生组织(WHO)体力状态≤ 2,胆红素
Previous small phase II trials have demonstrated that the combination of 5-fluorouracil (5FU) and cisplatin(CDDP) could have clinical activity in metastatic biliary tract cancer. This randomised phase II trial was designed to assess the activity and safety of a high-dose infusional weekly 5FU alone (HDFU) and the combination of 5FU, folinic acid (FA) and CDDP. Patients were included if they had histologically proven locally advanced or metastatic biliary tract carcinoma, World Health Organisation (WHO) performance status less than or equal to2, bilirubin