Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University (Henan Cancer Hospital), No. 127 Dongming Road, Zhengzhou, 450008, China.
Department of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital (Henan Cancer Hospital), Zhengzhou, China.
BMC Cancer. 2020 Apr 15;20(1):303. doi: 10.1186/s12885-020-06824-2.
Neoadjuvant therapy plus oesophagectomy has been accepted as the standard treatment for patients with potentially curable locally advanced oesophageal cancer. No completed randomized controlled trial (RCT) has directly compared neoadjuvant chemotherapy and neoadjuvant chemoradiation in patients with oesophageal squamous cell carcinoma (ESCC). The aim of the current RCT is to investigate the impact of neoadjuvant chemotherapy plus surgery and neoadjuvant chemoradiotherapy plus surgery on overall survival for patients with resectable locally advanced ESCC.
This open label, single-centre, phase III RCT randomized patients (cT2-T4aN + M0 and cT3-4aN0M0) in a 1:1 fashion to receive either the CROSS regimen (paclitaxel 50 mg/m; carboplatin (area under the curve = 2), q1w, 5 cycles; and concurrent radiotherapy, 41.4 Gy/23 F, over 5 weeks) or neoadjuvant chemotherapy (paclitaxel 175 mg/m; and cisplatin 75 mg/m, q21d, 2 cycles). Assuming a 12% 5-year overall survival difference in favour of the CROSS regimen, 80% power with a two-sided alpha level of 0.05 and a 5% dropout each year for an estimated 3 years enrolment, the power calculation requires 456 patients to be recruited (228 in each group). The primary endpoint is 5-year overall survival, with a minimum 5-year follow-up. The secondary endpoints include 5-year disease-free survival, toxicity, pathological complete response rate, postoperative complications, postoperative mortality and quality of life. A biobank of pre-treatment and resected tumour tissue will be built for translational research in the future.
This RCT directly compares a neoadjuvant chemotherapy regimen with a standard CROSS regimen in terms of overall survival for patients with locally advanced ESCC. The results of this RCT will provide an answer for the controversy regarding the survival benefits between the two treatment strategies.
NCT04138212, date of registration: October 24, 2019.
新辅助治疗加手术已被接受为局部晚期可治愈食管癌患者的标准治疗方法。目前尚无直接比较新辅助化疗和新辅助放化疗在食管鳞癌（ESCC）患者中的完成的随机对照试验（RCT）。本 RCT 的目的是研究新辅助化疗加手术和新辅助放化疗加手术对可切除局部晚期 ESCC 患者总生存的影响。
本开放标签、单中心、III 期 RCT 以 1:1 的比例将（cT2-T4aN+M0 和 cT3-4aN0M0）患者随机分配至接受 CROSS 方案（紫杉醇 50mg/m；卡铂（曲线下面积=2），q1w，5 个周期；同期放疗，41.4Gy/23F，5 周）或新辅助化疗（紫杉醇 175mg/m；顺铂 75mg/m，q21d，2 个周期）。假设 CROSS 方案的 5 年总生存率有 12%的优势，80%的效能，双侧α水平为 0.05，每年估计有 3 年的入组率为 5%，则需要招募 456 例患者（每组 228 例）。主要终点为 5 年总生存率，最低随访时间为 5 年。次要终点包括 5 年无病生存率、毒性、病理完全缓解率、术后并发症、术后死亡率和生活质量。将建立一个预处理和切除肿瘤组织的生物库，用于未来的转化研究。
本 RCT 直接比较了新辅助化疗方案与标准 CROSS 方案在局部晚期 ESCC 患者总生存方面的差异。本 RCT 的结果将为两种治疗策略的生存获益争议提供答案。
NCT04138212，注册日期：2019 年 10 月 24 日。
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