Despite obvious advances over the last decades, locally advanced adenocarcinomas of the gastroesophageal junction (GEJ) still carry a dismal prognosis with overall 5-year survival rates of less than 50% even when using modern optimized treatment protocols such as perioperative chemotherapy based on the FLOT regimen or radiochemotherapy. Therefore the question remains whether neoadjuvant chemotherapy or neoadjuvant radiochemotherapy is eliciting the best results in patients with GEJ cancer. Hence, an adequately powered multicentre trial comparing both therapeutic strategies is clearly warranted. The RACE trial is a an investigator initiated multicenter, prospective, randomized, stratified phase III clinical trial and seeks to investigate the role of preoperative induction chemotherapy (2 cycles of FLOT: 5-FU, leucovorin, oxaliplatin, docetaxel) with subsequent preoperative radiochemotherapy (oxaliplatin weekly, 5-FU plus concurrent fractioned radiotherapy to a dose of 45 Gy) compared to preoperative chemotherapy alone (4 cycles of FLOT), both followed by resection and postoperative completion of chemotherapy (4 cycles of FLOT), in the treatment of locally advanced, potentially resectable adenocarcinoma of the gastroesophageal junction. Patients with cT3–4, any N, M0 or cT2 N+, M0 adenocarcinoma of the GEJ are eligible for inclusion. The RACE trial aims to enrol 340 patients to be allocated to both treatment arms in a 1:1 ratio stratified by tumour site. The primary endpoint of the trial is progression-free survival assessed with follow-up of maximum 60 months. Secondary endpoints include overall survival, R0 resection rate, number of harvested lymph nodes, site of tumour relapse, perioperative morbidity and mortality, safety and toxicity and quality of life. The RACE trial compares induction chemotherapy with FLOT followed by preoperative oxaliplatin and 5-Fluorouracil-based chemoradiation versus preoperative chemotherapy with FLOT alone, both followed by surgery and postoperative completion of FLOT chemotherapy in the treatment of locally advanced, non-metastatic adenocarcinoma of the GEJ. The trial aims to show superiority of the combined chemotherapy/radiochemotherapy treatment, assessed by progression-free survival, over perioperative chemotherapy alone. ClinicalTrials.gov ; NCT04375605 ; Registered 4th May 2020;

中文翻译：

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RACE试验：胃食管连接处局部晚期，可切除的腺癌患者的新辅助放化疗与化学疗法的比较-AIO，ARO和DGAV的一项随机III期联合研究。

尽管在过去的几十年中取得了明显的进展，但即使使用现代优化的治疗方案（例如基于FLOT的围手术期化疗），胃食管连接处（GEJ）的局部晚期腺癌仍预后不佳，总体5年生存率不到50％方案或放射化学疗法。因此，问题仍然在于，新辅助化疗或新辅助放化疗能否在GEJ癌症患者中获得最佳结果。因此，显然有必要进行比较两种治疗策略的充分动力的多中心试验。RACE试验是由研究人员发起的一项多中心，前瞻性，随机，分层的III期临床试验，旨在研究术前诱导化疗的作用（2个周期的FLOT：5-FU，亚叶酸，奥沙利铂，多西他赛）与随后的术前放化疗（奥沙利铂每周，5-FU联合分次放疗至45 Gy剂量）相比，单独进行术前化疗（4周期FLOT），然后进行切除和术后化疗（4周期FLOT） ），用于治疗胃食管交界处的局部晚期，可能切除的腺癌。患有cT3-4，GEN的任何N，M0或cT2 N +，M0腺癌的患者均符合纳入条件。RACE试验旨在招募340名患者，按照肿瘤部位分层以1：1的比例分配给两个治疗组。该试验的主要终点是无进展生存期，最多随访60个月。次要终点包括总体生存率，R0切除率，收获的淋巴结数目，肿瘤复发的部位，围手术期的发病率和死亡率，安全性和毒性以及生活质量。RACE试验比较了FLOT诱导化疗，术前以奥沙利铂和5-氟尿嘧啶为基础的化学放疗与术前单纯FLOT化疗，术后及FLOT化疗完成以治疗局部晚期，非转移性GEJ腺癌的比较。该试验旨在显示通过无进展生存期评估的联合化疗/放化疗联合治疗优于单纯围手术期化疗的优势。ClinicalTrials.gov; NCT04375605; 2020年5月4日注册; RACE试验比较了FLOT诱导化疗与术前以奥沙利铂和5-氟尿嘧啶为基础的化学放疗与单纯FLOT术前化疗，FLOT化疗在术后和术后完成局部GEGE局部非转移性腺癌的治疗之间的比较。 。该试验旨在显示通过无进展生存期评估的联合化疗/放化疗联合治疗优于单纯围手术期化疗的优势。ClinicalTrials.gov; NCT04375605; 2020年5月4日注册; RACE试验比较了FLOT诱导化疗，术前以奥沙利铂和5-氟尿嘧啶为基础的化学放疗与术前单纯FLOT化疗，术后及FLOT化疗完成以治疗局部晚期，非转移性GEJ腺癌的比较。该试验旨在显示通过无进展生存期评估的联合化疗/放化疗联合治疗优于单纯围手术期化疗的优势。ClinicalTrials.gov; NCT04375605; 2020年5月4日注册; 该试验旨在显示通过无进展生存期评估的联合化疗/放化疗联合治疗优于单纯围手术期化疗的优势。ClinicalTrials.gov; NCT04375605; 2020年5月4日注册; 该试验旨在显示通过无进展生存期评估的联合化疗/放化疗联合治疗优于单纯围手术期化疗的优势。ClinicalTrials.gov; NCT04375605; 2020年5月4日注册;