Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1-1-2 Nakao, 241-0815, Yokohama, Asahi-ku, Japan.
BMC Cancer. 2012 Jul 23;12:307. doi: 10.1186/1471-2407-12-307.
On the basis of international clinical trials, capecitabine plus cisplatin (XP) as a first-line treatment of advanced gastric cancer is considered a global standard regimen. However, the usefulness of XP as compared with S-1 plus cisplatin (SP), which is considered standard therapy in Japan, has not yet been assessed.
METHODS/DESIGN: This is a multicenter randomized phase II trial to elucidate the efficacy of XP as compared with SP for first-line treatment of advanced gastric cancer. Patients with unresectable metastatic or recurrent gastric cancer, 20-74 years of age and human epidermal growth factor 2 (HER2)-negative status, will be assigned in a 1:1 ratio to receive either S-1 40 mg/m2 bid for 21 days plus cisplatin 60 mg/m2 (day 8) every 5-week cycle or capecitabine 1000 mg/m2 bid for 14 days plus cisplatin 80 mg/m2 (day 1) every 3-week cycle. Patients will be also asked to the analysis of tumor tissues for translational investigations. The Primary endpoint is progression-free survival and secondary endpoints are overall survival, time to treatment failure, tumor response rate and safety. These comparisons will also be evaluated in terms of biomarkers. Planned sample size is 100 (50 in each arm), which is appropriate for this trial.
Fluoropyrimidine plus cisplatin combination is the standard regimen of the first line treatment for advanced gastric cancer. Both S-1 and capecitabine are the prodrug of 5-FU but differ from their process of metabolism. Result of this trial and translational research will provide the important clues to prepare the individualized therapy for advanced gastric cancer in the near future.
ClinicalTrials.gov Identifier NCT01406249.
以国际临床试验为基础，卡培他滨联合顺铂（XP）作为晚期胃癌的一线治疗被认为是全球标准方案。然而，XP 与在日本被认为是标准治疗的 S-1 联合顺铂（SP）相比的有效性尚未得到评估。
方法/设计：这是一项多中心随机 2 期临床试验，旨在阐明 XP 作为晚期胃癌一线治疗与 SP 相比的疗效。将不可切除的转移性或复发性胃癌患者（20-74 岁，人表皮生长因子 2（HER2）阴性）以 1:1 的比例随机分配，接受 S-1 40mg/m2 bid 治疗 21 天，加顺铂 60mg/m2（第 8 天），每 5 周为一个周期；或卡培他滨 1000mg/m2 bid 治疗 14 天，加顺铂 80mg/m2（第 1 天），每 3 周为一个周期。还将要求患者对肿瘤组织进行分析，进行转化研究。主要终点是无进展生存期，次要终点是总生存期、治疗失败时间、肿瘤反应率和安全性。这些比较也将根据生物标志物进行评估。计划的样本量为 100 例（每组 50 例），适用于该试验。
氟嘧啶联合顺铂的联合方案是晚期胃癌一线治疗的标准方案。S-1 和卡培他滨都是 5-FU 的前体药物，但它们的代谢过程不同。该试验的结果和转化研究将为未来准备晚期胃癌的个体化治疗提供重要线索。
ClinicalTrials.gov 标识符 NCT01406249。
