比较局部进展期胃癌或食管胃结合部腺癌患者术前放化疗与术前化疗的随机 III 期临床试验方案：PREACT。
Study protocol of a randomized phase III trial of comparing preoperative chemoradiation with preoperative chemotherapy in patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma: PREACT.
机构信息
Department of Gastric Cancer Surgery, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China.
出版信息
BMC Cancer. 2019 Jun 20;19(1):606. doi: 10.1186/s12885-019-5728-8.
BACKGROUND
The prognosis of patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma is still dismal. There are no standard treatment strategies for these patients. Multidisciplinary team (MDT) approach is a good choice for making a high-quality decision. Generally, MDT will recommend these patients to receive preoperative chemotherapy or preoperative chemoradiation based on all kinds of treatment guidelines. However, the preferred preoperative treatment is still not established. In order to solve this problem, we carry out this randomized phase III trial of comparing preoperative chemoradiation with preoperative chemotherapy in patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma.
METHODS
Eligible patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma are randomized to receive preoperative chemoradiation or preoperative chemotherapy, followed by surgery and postoperative chemotherapy. In the preoperative chemoradiation arm (Pre-CRT), patients receive two cycles of S-1 and oxaliplatin (SOX), chemoradiation, then followed by surgery and three more cycles of SOX chemotherapy. In the preoperative chemotherapy arm (Pre-CT), patients receive three cycles of SOX, following surgery three more cycles of SOX are given. The primary endpoint of this trial is to verify that preoperative chemoradiation could significantly improve the 3-year disease free survival (DFS) of patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma compared to preoperative chemotherapy.
DISCUSSION
The results from this trial will provide important information about whether preoperative chemoradiation could improve survival compared to preoperative chemotherapy among patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03013010. First posted January 6, 2017.
背景
局部晚期胃或胃食管交界腺癌患者的预后仍较差。对于这些患者，尚无标准的治疗策略。多学科团队（MDT）方法是做出高质量决策的不错选择。通常，MDT 会根据各种治疗指南建议这些患者接受术前化疗或术前放化疗。但是，首选的术前治疗方法尚未确定。为了解决这个问题，我们开展了这项比较局部晚期胃或胃食管交界腺癌患者术前放化疗与术前化疗的随机 III 期试验。
方法
符合条件的局部晚期胃或胃食管交界腺癌患者被随机分配接受术前放化疗或术前化疗，然后进行手术和术后化疗。在术前放化疗组（Pre-CRT）中，患者接受两周期 S-1 和奥沙利铂（SOX）化疗、放化疗，然后进行手术，并再接受三个周期 SOX 化疗。在术前化疗组（Pre-CT）中，患者接受三个周期 SOX，手术后再给予三个周期 SOX。该试验的主要终点是验证术前放化疗与术前化疗相比，能否显著提高局部晚期胃或胃食管交界腺癌患者的 3 年无病生存率（DFS）。
讨论
该试验的结果将提供有关局部晚期胃或胃食管交界腺癌患者中，术前放化疗与术前化疗相比是否能改善生存的重要信息。
试验注册
ClinicalTrials.gov 标识符：NCT03013010。首次发布于 2017 年 1 月 6 日。
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