The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, 450008, China.
Xinyang Hospital Affiliated to Zhengzhou University & Xinyang Central Hospital, Xinyang, 464000, China.
BMC Cancer. 2024 Mar 7;24(1):321. doi: 10.1186/s12885-024-12002-5.
Definitive concurrent chemoradiotherapy (dCCRT) is the gold standard for the treatment of locally advanced esophageal squamous cell carcinoma (ESCC). However, the potential benefits of consolidation chemotherapy after dCCRT in patients with esophageal cancer remain debatable. Prospective randomized controlled trials comparing the outcomes of dCCRT with or without consolidation chemotherapy in patients with ESCC are lacking. In this study, we aim to generate evidence regarding consolidation chemotherapy efficacy in patients with locally advanced, inoperable ESCC.
This is a multicenter, prospective, open-label, phase-III randomized controlled trial comparing non-inferiority of dCCRT alone to consolidation chemotherapy following dCCRT. In total, 600 patients will be enrolled and randomly assigned in a 1:1 ratio to receive either consolidation chemotherapy after dCCRT (Arm A) or dCCRT alone (Arm B). Overall survival will be the primary endpoint, whereas progression-free survival, locoregional progression-free survival, distant metastasis-free survival, and treatment-related toxicity will be the secondary endpoints.
This study aid in further understanding the effects of consolidation chemotherapy after dCCRT in patients with locally advanced, inoperable ESCC.
ChiCTR1800017646.
根治性同期放化疗（dCCRT）是治疗局部晚期食管鳞状细胞癌（ESCC）的金标准。然而，在食管癌患者中，dCCRT 后巩固化疗的潜在益处仍存在争议。缺乏比较 ESCC 患者接受 dCCRT 加或不加巩固化疗的结局的前瞻性随机对照试验。在这项研究中，我们旨在为局部晚期不可切除的 ESCC 患者提供关于巩固化疗疗效的证据。
这是一项多中心、前瞻性、开放标签、III 期随机对照试验，比较 dCCRT 单独治疗与 dCCRT 后巩固化疗的非劣效性。总共将招募 600 名患者，并以 1:1 的比例随机分配接受 dCCRT 后巩固化疗（A 组）或 dCCRT 单独治疗（B 组）。总生存期将是主要终点，而无进展生存期、局部区域无进展生存期、无远处转移生存期和治疗相关毒性将是次要终点。
这项研究有助于进一步了解局部晚期不可切除 ESCC 患者 dCCRT 后巩固化疗的效果。
ChiCTR1800017646。
