POF（紫杉醇/奥沙利铂/5-氟尿嘧啶/亚叶酸钙）与SOX/CAPOX/FOLFOX作为根治性切除的III期胃癌术后辅助化疗的比较：一项随机对照试验（FNF-014试验）的研究方案
POF (paclitaxel/oxaliplatin/5-fluorouracil/leucovorin) vs. SOX/CAPOX/FOLFOX as a postoperative adjuvant chemotherapy for curatively resected stage III gastric cancer: Study protocol for a randomized controlled trial, FNF-014 trial.
作者信息
Su Liyu, Zhao Shen, Yin Yi, Huang Feng, Zhu Jinfeng, Chen Luchuan, Lin Rongbo
机构信息
Department of Gastrointestinal Medical Oncology, Fujian Cancer Hospital and Fujian Medical University Cancer Hospital, Fuzhou, China.
Fujian Key Laboratory of Translational Cancer Medicine, Fuzhou, China.
出版信息
Front Med (Lausanne). 2022 Aug 2;9:861777. doi: 10.3389/fmed.2022.861777. eCollection 2022.
BACKGROUND
Postoperative chemotherapy is a standard treatment for stage II and III gastric cancer in Asia. With regard to single-agent or doublet, the need for improvement has consistently been pointed out because of the relatively poor outcome for patients with stage III gastric cancer. Triplet has shown significant survival benefits in the perioperative setting. We conducted a randomized, multicenter, phase III study to compare triplet to doublet regimens for patients with stage III gastric cancer.
METHODS
This is currently enrolling patients ( = 230) with pathologic stage III gastric cancer after D2 lymph node dissection and achieved R0 resection. Patients are randomized 1:1 and stratified by tumor stage (IIIA, IIIB, or IIIC, AJCC 8th) into POF or SOX/CAPOX/FOLFOX. S-1 and oxaliplatin (SOX): oxaliplatin 130 mg/m on day 1, oral S-1 80-120 mg/m divided by two on days 1-14 every 21 days for 8 cycles. Capecitabine and oxaliplatin (CAPOX): oxaliplatin 130 mg/m on day 1, oral capecitabine 1000 mg/m twice daily on days 1-14 every 21 days for 8 cycles. Folinic acid (or leucovorin), 5-fluorouracil and oxaliplatin (FOLFOX): oxaliplatin 85 mg/m, levo-leucovorin 200 mg/m, and 5-fluorouracil (5-FU) 400 mg/m bolus on day 1, then 5-FU 2400 mg/m continuous infusion over 46 h, every 14 days for 12 cycles. Three doublets were chosen by the clinicians. Paclitaxel, oxaliplatin, 5-fluorouracil, and leucovorin (POF): paclitaxel 135 mg/m, followed by FOLFOX omitted 5-FU bolus, every 14 days for 12 cycles. The primary end point is 3-year disease-free survival (3-year-DFS). Secondary end points are overall survival (OS) and safety (any adverse event).
DISCUSSION
The results of this study will help establish postoperative clinical evidence for patients with locally advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
CLINICAL TRIAL REGISTRATION
[www.ClinicalTrials.gov], identifier [NCT0378826].
背景
术后化疗是亚洲II期和III期胃癌的标准治疗方法。关于单药或双药方案，由于III期胃癌患者的预后相对较差，一直有人指出需要改进。三联疗法在围手术期已显示出显著的生存获益。我们进行了一项随机、多中心、III期研究，比较三联疗法与双药方案用于III期胃癌患者的疗效。
方法
本研究目前正在招募230例经D2淋巴结清扫且实现R0切除的病理III期胃癌患者。患者按1:1随机分组，并根据肿瘤分期（IIIA、IIIB或IIIC，美国癌症联合委员会第8版）分层，分为POF组或SOX/CAPOX/FOLFOX组。S-1和奥沙利铂（SOX）：奥沙利铂130mg/m²，第1天给药，口服S-1 80 - 120mg/m²，分两次服用，第1 - 14天，每21天为一周期，共8个周期。卡培他滨和奥沙利铂（CAPOX）：奥沙利铂130mg/m²，第1天给药，口服卡培他滨1000mg/m²，每日两次，第1 - 14天，每21天为一周期，共8个周期。亚叶酸（或甲酰四氢叶酸）、5-氟尿嘧啶和奥沙利铂（FOLFOX）：奥沙利铂85mg/m²，左亚叶酸200mg/m²，5-氟尿嘧啶（5-FU）400mg/m²静脉推注，第1天，然后5-FU 2400mg/m²持续输注46小时，每14天为一周期，共12个周期。三种双药方案由临床医生选择。紫杉醇、奥沙利铂、5-氟尿嘧啶和亚叶酸（POF）：紫杉醇135mg/m²，随后省略FOLFOX方案中的5-FU静脉推注，每14天为一周期，共12个周期。主要终点是3年无病生存率（3-year-DFS）。次要终点是总生存期（OS）和安全性（任何不良事件）。
讨论
本研究结果将有助于为局部晚期胃腺癌或胃食管交界腺癌患者建立术后临床证据。
临床试验注册
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