Comparison of paclitaxel in combination with cisplatin (TP), carboplatin (TC) or fluorouracil (TF) concurrent with radiotherapy for patients with local advanced oesophageal squamous cell carcinoma: a three-arm phase III randomized trial (ESO-Shanghai 2).
Comparison of paclitaxel in combination with cisplatin (TP), carboplatin (TC) or fluorouracil (TF) concurrent with radiotherapy for patients with local advanced oesophageal squamous cell carcinoma: a three-arm phase III randomized trial (ESO-Shanghai 2).
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DOI：
10.1136/bmjopen-2017-020785
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发表时间：
2018-10-21
期刊：
影响因子：
2.9
通讯作者：
Zhao K
中科院分区：
文献类型：
--
作者：
Ai D;Chen Y;Liu Q;Zhang J;Deng J;Zhu H;Ren W;Zheng X;Li Y;Wei S;Ye J;Zhou J;Lin Q;Luo H;Cao J;Li J;Huang G;Wu K;Fan M;Yang H;Zhu Z;Zhao W;Li L;Fan J;Badakhshi H;Zhao K
同步放化疗是不适合手术的局部晚期食管癌患者的标准治疗方法。紫杉醇是一种抗食道癌的活性药物，并已被证明是一种有效的放射增敏剂。已有多项研究评估基于紫杉醇的放化疗治疗食管癌的效果，其结果令人鼓舞。然而，顺铂（TP）、卡铂（TC）或氟尿嘧啶（TF）与紫杉醇联合放疗中哪一种方案能提供最佳预后且不良事件最少，目前尚不清楚，并且很少有研究关注这一领域。本研究的目的是确认TF对TP或TF对TC同步放疗在总生存方面的优先顺序，并为局部晚期食管癌患者提出可行有效的方案。 ESO-上海2是一项三组、多中心、开放标签、随机III期临床试验。该研究于2015年7月启动，预计纳入期限为4年。该研究比较了食管鳞状细胞癌 (OSCC) 患者的两对治疗方案：TF 与 TP 以及 TF 与 TC 联合根治性放疗。经组织学证实的 OSCC（根据国际癌症控制第六联盟肿瘤、淋巴结、转移分类为临床 II、III 或 IVa 期）且既往未接受任何针对食管癌的化疗、放疗或手术治疗的患者将符合资格。总共 321 名患者将被随机分配到三个治疗组，比例为 1:1:1。患者按淋巴结状态（N0、N1、M1a）进行分层。主要终点是总生存期，次要终点是无进展生存期和不良事件。该试验已获得复旦大学附属肿瘤医院机构审查委员会的批准。试验结果将通过同行评审的科学期刊和会议演讲传播。该试验于2015年7月启动，目前正在上述所有参与机构招募患者。 NCT02459457。
Concurrent chemoradiation is the standard therapy for patients with local advanced oesophageal carcinoma unsuitable for surgery. Paclitaxel is an active agent against oesophageal cancer and it has been proved as a potent radiation sensitiser. There have been multiple studies evaluating paclitaxel-based chemoradiation in oesophageal cancer, of which the results are inspiring. However, which regimen, among cisplatin (TP), carboplatin (TC) or fluorouracil (TF) in combination with paclitaxel concurrent with radiotherapy, provides best prognosis with minimum adverse events is still unknown and very few studies focus on this field. The purpose of this study is to confirm the priority of TF to TP or TF to TC concurrent with radiotherapy in terms of overall survival and propose a feasible and effective plan for patients with local advanced oesophageal cancer. ESO-Shanghai 2 is a three-arm, multicenter, open-labelled, randomised phase III clinical trial. The study was initiated in July 2015 and the duration of inclusion is expected to be 4 years. The study compares two pairs of regimen: TF versus TP and TF versus TC concurrent with definitive radiotherapy for patients with oesophageal squamous cell carcinoma (OSCC). Patients with histologically confirmed OSCC (clinical stage II, III or IVa based on the sixth Union for International Cancer Control-tumour, node, metastasis classification) and without any prior treatment of chemotherapy, radiotherapy or surgery against oesophageal cancer will be eligible. A total of 321 patients will be randomised and allocated in a 1:1:1 ratio to the three treatment groups. Patients are stratified by lymph node status (N0, N1, M1a). The primary endpoint is overall survival and the secondary endpoint is progression-free survival and adverse events. This trial has been approved by the Fudan University Shanghai Cancer Centre Institutional Review Board. Trial results will be disseminated via peer reviewed scientific journals and conference presentations. The trial was initiated in July 2015 and is currently recruiting patients in all of the participating institutions above. NCT02459457.
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影响因子：
3.8
作者：
Mohammad, Nadia Haj;Hulshof, Maarten C. C. M.;van Laarhoven, Hanneke W. M.
通讯作者：
van Laarhoven, Hanneke W. M.
影响因子：
2
作者：
Lakatos, E
通讯作者：
Lakatos, E
影响因子：
254.7
作者：
Torre, Lindsey A.;Bray, Freddie;Jemal, Ahmedin
通讯作者：
Jemal, Ahmedin
DOI：
10.1093/jnci/86.14.1086
发表时间：
1994-07-20
期刊：
JOURNAL OF THE NATIONAL CANCER INSTITUTE
影响因子：
--
作者：
AJANI, JA;ILSON, DH;KELSEN, DP
通讯作者：
KELSEN, DP
影响因子：
45.3
作者：
Ajani, Jaffer A.;Winter, Kathryn;Willett, Christopher G.
通讯作者：
Willett, Christopher G.