Currently, adjuvant therapy is not recommended for patients with thoracic esophageal squamous cell cancer (TESCC) after radical surgery, and a proportion of these patients go on to develop locoregional recurrence (LRR) within 2 years. Besides, there is no evidence for salvage chemoradiation therapy (CRT) in patients with residual tumor after esophagectomy (R1/R2 resection). In addition, factors like different failure patterns and relationship with normal organs influence the decision for salvage strategy. Here, we aimed to design a modularized salvage CRT strategy for patients without a chance of salvage surgery according to different failure patterns (including R1/R2 resection), and further evaluated its efficacy and safety. Our study was designed as a one arm, multicenter, prospective clinical trial. All enrolled patients were stratified in a stepwise manner based on the nature of surgery (R0 or R1/2), recurrent lesion diameter, involved regions, and time-to-recurrence, and were further assigned to undergo either elective nodal irradiation or involved field irradiation. Then, radiation technique and dose prescription were modified according to the distance from the recurrent lesion to the thoracic stomach or intestine. Ultimately, four treatment plans were established. This prospective study provided high-level evidence for clinical salvage management in patients with TESCC who developed LRR after radical surgery or those who underwent R1/R2 resection. Prospectively Registered. ClinicalTrials.gov NCT03731442 , Registered November 6, 2018.

中文翻译：

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食管癌患者根治性手术或姑息性手术后复发的挽救性化学放射治疗：一项前瞻性，多中心临床试验方案。

目前，不建议对根治性手术后的胸段食管鳞状细胞癌（TESCC）患者进行辅助治疗，这些患者中有一部分在2年内会继续发生局部复发（LRR）。此外，没有证据表明在食管切除术（R1 / R2切除）后残留肿瘤的患者中进行挽救性化学放射治疗（CRT）。此外，不同的失败模式以及与正常器官的关系等因素也会影响挽救策略的决策。在这里，我们旨在根据不同的失败模式（包括R1 / R2切除）为没有机会进行挽救手术的患者设计模块化挽救CRT策略，并进一步评估其有效性和安全性。我们的研究设计为单臂，多中心，前瞻性临床试验。根据手术的性质（R0或R1 / 2），病灶复发直径，受累部位和复发时间，以分级方式对所有入组患者进行分层，并进一步分配其接受选择性淋巴结照射或受累野辐射。然后，根据从复发性病变到胸胃或肠道的距离来修改放射技术和剂量处方。最终，制定了四个治疗计划。这项前瞻性研究为根治性手术后发生LRR或接受R1 / R2切除的TESCC患者的临床挽救管理提供了高级证据。预先注册。ClinicalTrials.gov NCT03731442，2018年11月6日注册。和复发时间，并进一步分配进行选择性淋巴结照射或野外照射。然后，根据从复发性病变到胸胃或肠道的距离来修改放射技术和剂量处方。最终，制定了四个治疗计划。这项前瞻性研究为根治性手术后发生LRR或接受R1 / R2切除的TESCC患者的临床挽救管理提供了高级证据。预先注册。ClinicalTrials.gov NCT03731442，2018年11月6日注册。和复发时间，并进一步分配进行选择性淋巴结照射或野外照射。然后，根据从复发性病变到胸胃或肠道的距离来修改放射技术和剂量处方。最终，制定了四个治疗计划。这项前瞻性研究为根治性手术后发生LRR或接受R1 / R2切除的TESCC患者的临床挽救管理提供了高级证据。预先注册。ClinicalTrials.gov NCT03731442，2018年11月6日注册。根据从复发性病变到胸腔或肠道的距离来修改放射线技术和剂量处方。最终，制定了四个治疗计划。这项前瞻性研究为根治性手术后发生LRR或接受R1 / R2切除的TESCC患者的临床挽救管理提供了高级证据。预先注册。ClinicalTrials.gov NCT03731442，2018年11月6日注册。根据从复发性病变到胸腔或肠道的距离来修改放射线技术和剂量处方。最终，制定了四个治疗计划。这项前瞻性研究为根治性手术后发生LRR或接受R1 / R2切除的TESCC患者的临床挽救管理提供了高级证据。预先注册。ClinicalTrials.gov NCT03731442，2018年11月6日注册。