局部晚期宫颈癌新辅助化疗联合放化疗与单纯放化疗的疗效和副作用比较：一项随机对照试验研究方案。
Comparison of outcomes and side effects for neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation vs. chemoradiation alone in stage IIB-IVA cervical cancer: study protocol for a randomized controlled trial.
机构信息
Department of Gynecology and Obstetrics, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 200025, People's Republic of China.
Department of Radiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 200025, People's Republic of China.
出版信息
Trials. 2022 Jan 10;23(1):29. doi: 10.1186/s13063-021-05986-z.
BACKGROUND
Currently, the standard treatment for locally advanced cervical cancer is concurrent chemoradiation (CCRT). The effect of neoadjuvant chemotherapy in advanced cervical cancer is controversial. Studies have shown that the addition of a weekly regimen of neoadjuvant chemotherapy (NACT) followed by CCRT may be superior to a thrice-weekly regimen of NACT and CCRT. Among patients who had not received prior cisplatin, a cisplatin and paclitaxel (TP) regimen resulted in longer overall survival than other regimens. This study aims to investigate the feasibility, safety, and efficacy of NACT with weekly TP followed by CCRT.
METHODS
This is a prospective, randomized, open-labeled, multicentered phase III study. Based on a 65% of 2-year disease-free survival (DFS) rate in the CCRT group and 80% of that in NACT followed by CCRT group, and on prerequisite conditions including an 8% loss to follow-up, a two-sided 5% of type I error probability, and an 80% of power, a total of 300 cases were required for enrollment. Patients with IIB-IVA cervical cancer will be randomly allocated in a 1:1 ratio to one of two intervention arms. In the study arm, patients will receive dose-dense cisplatin (40 mg/m) and paclitaxel (60 mg/m) weekly for 4 cycles followed by CCRT (45 Gy in 5 weeks concurrent with cisplatin 40 mg/m weekly) plus image-guided adaptive brachytherapy (IGBRT). In the control arm, patients will undergo CCRT treatment. The primary endpoint of the study is 2-year disease-free survival (DFS); the secondary endpoints are 5-year overall survival (OS) and disease-free survival (DFS), the response rate 3 months after treatment completion, grade III/IV adverse effects, and quality of life, and potential biomarkers for predicting treatment response will also be studied.
DISCUSSION
The data gathered from the study will be used to determine whether NACT with weekly TP followed by CCRT may become an optimized treatment for locally advanced cervical cancer.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR1900025327. Registered on 24 August 2019. medresman.org.cn ChiCTR1900025326.
背景
目前，局部晚期宫颈癌的标准治疗方法是同期放化疗（CCRT）。新辅助化疗在晚期宫颈癌中的作用存在争议。研究表明，每周一次的新辅助化疗（NACT）加 CCRT 可能优于每周三次的 NACT 和 CCRT。对于未接受顺铂治疗的患者，顺铂联合紫杉醇（TP）方案的总生存期长于其他方案。本研究旨在探讨每周 TP 新辅助化疗加 CCRT 的可行性、安全性和疗效。
方法
这是一项前瞻性、随机、开放标签、多中心 III 期研究。基于 CCRT 组 2 年无疾病生存率（DFS）为 65%，NACT 后加 CCRT 组为 80%，并考虑到 8%的随访丢失率、双侧 5%的Ⅰ类错误概率和 80%的效能，共需要入组 300 例患者。IIB-IVA 期宫颈癌患者将按照 1:1 的比例随机分配到两组干预组之一。在研究组中，患者将接受每周 4 个周期的密集顺铂（40mg/m2）和紫杉醇（60mg/m2）治疗，然后进行 CCRT（5 周内给予 45Gy 同时每周给予顺铂 40mg/m2）加图像引导自适应近距离放疗（IGBRT）。在对照组中，患者将接受 CCRT 治疗。该研究的主要终点是 2 年无病生存率（DFS）；次要终点是 5 年总生存率（OS）和无病生存率（DFS）、治疗后 3 个月的反应率、III/IV 级不良事件和生活质量，以及预测治疗反应的潜在生物标志物。
讨论
该研究收集的数据将用于确定每周 TP 新辅助化疗加 CCRT 是否可能成为局部晚期宫颈癌的优化治疗方法。
试验注册
中国临床试验注册中心 ChiCTR1900025327。注册于 2019 年 8 月 24 日。medresman.org.cn ChiCTR1900025326。
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