Since the development of three-dimensional conformal radiotherapy and intensity-modulated radiotherapy (IMRT), no prospective study has investigated whether concurrent chemoradiotherapy (SIB-IMRT with 60 Gy) remains superior to radiotherapy (SIB-IMRT) alone for unresectable esophageal cancer (EC). Furthermore, the optimal therapeutic regimen for patients who cannot tolerate concurrent chemoradiotherapy is unclear. We recently completed a phase I/II radiation dose-escalation trial using simultaneous integrated boost (SIB), elective nodal irradiation, and concurrent chemotherapy for unresectable EC. We now intend to conduct a prospective, phase III, randomized study of SIB-IMRT with or without concurrent chemotherapy. We aim to find a safe, practical, and effective therapeutic regimen to replace the conventional segmentation (1.8–2.0 Gy) treatment mode (radiotherapy ± chemotherapy) for unresectable EC. This two-arm, open, randomized, multicenter, phase III trial will recruit esophageal squamous cell carcinoma patients (stage IIA–IVB [UICC 2002]; IVB only with metastasis to the supraclavicular or celiac lymph nodes). In all, 164 patients will be randomized using a 1:1 allocation ratio, and stratified by study site and disease stage, especially the extent of lymph node metastasis. Patients in the SIB arm will receive definitive SIB radiotherapy (95% planning target volume/planning gross tumor volume, 50.4 Gy/59.92 Gy/28 f, equivalent dose in 2-Gy fractions = 60.62 Gy). Patients in the SIB + concurrent chemotherapy arm will receive definitive SIB radiotherapy with weekly paclitaxel and a platinum-based drug (5–6 weeks). Four cycles of consolidated chemoradiotherapy will also be recommended. The primary objective is to compare the 1-year, 2-year, and 3-year overall survival of the SIB + chemotherapy group and SIB groups. Secondary objectives include progression-free survival, local recurrence-free rate, completion rate, and adverse events. Detailed radiotherapy protocol and quality-assurance procedures have been incorporated into this trial. In unresectable, locally advanced EC, a safe and effective total radiotherapy dose and reasonable segmentation doses are required for the clinical application of SIB-IMRT + two-drug chemotherapy. Whether this protocol will replace the standard treatment regimen will be prospectively investigated. The effects of SIB-IMRT in patients with poor physical condition who cannot tolerate definitive chemoradiotherapy will also be investigated. clinicaltrials.gov ( NCT03308552 , November 1, 2017).

中文翻译：

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对食管癌患者同时进行综合升压调强放疗（联合或不联合化疗）的多中心前瞻性 III 期临床随机研究：3JECROG P-02 研究方案。

自三维适形放疗和调强放疗（IMRT）发展以来，尚无前瞻性研究探讨同步放化疗（60 Gy的SIB-IMRT）对于不可切除的食管癌（EC）是否仍优于单独放疗（SIB-IMRT）。 ）。此外，对于不能耐受同步放化疗的患者的最佳治疗方案尚不清楚。我们最近完成了一项 I/II 期放射剂量递增试验，使用同步综合加强 (SIB)、选择性淋巴结照射和同步化疗治疗不可切除的 EC。我们现在打算对联合或不联合化疗的 SIB-IMRT 进行前瞻性 III 期随机研究。我们的目标是寻找一种安全、实用、有效的治疗方案来替代不可切除EC的传统分段（1.8-2.0Gy）治疗模式（放疗±化疗）。这项双臂、开放、随机、多中心 III 期试验将招募食管鳞状细胞癌患者（IIA-IVB 期 [UICC 2002]；IVB 仅伴有锁骨上或腹腔淋巴结转移）。总共 164 名患者将按照 1:1 的分配比例进行随机分配，并根据研究地点和疾病分期（尤其是淋巴结转移的程度）进行分层。SIB 组中的患者将接受明确的 SIB 放疗（95% 计划靶体积/计划总肿瘤体积，50.4 Gy/59.92 Gy/28 f，2 Gy 分数的等效剂量 = 60.62 Gy）。SIB + 同步化疗组的患者将接受每周一次的紫杉醇和铂类药物的确定性 SIB 放疗（5-6 周）。还将建议进行四个周期的综合放化疗。主要目的是比较 SIB + 化疗组和 SIB 组的 1 年、2 年和 3 年总生存率。次要目标包括无进展生存期、局部无复发率、完成率和不良事件。详细的放射治疗方案和质量保证程序已纳入该试验。对于不可切除的局部晚期EC，SIB-IMRT+两药化疗的临床应用需要安全有效的总放疗剂量和合理的分段剂量。该方案是否会取代标准治疗方案将进行前瞻性研究。还将研究 SIB-IMRT 对身体状况不佳且无法耐受根治性放化疗的患者的影响。ClinicalTrials.gov（NCT03308552，2017 年 11 月 1 日）。