Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17 South Panjiayuan lane, Chaoyang District, Beijing, 100021, China.
Department of Radiotherapy, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.
BMC Cancer. 2020 Feb 18;20(1):130. doi: 10.1186/s12885-020-6592-2.
Preoperative chemoradiotherapy (CRT) followed by surgery is the most common approach for patients with resectable esophageal cancer. Nevertheless, considerable numbers of esophageal-cancer patients undergo surgery as the first treatment. The benefit of neoadjuvant therapy might only be for patients with a pathologic complete response, so stratified research is necessary. Postoperative treatments have important roles because of the poor survival rates of patients with stage-IIB/III disease treated with resection alone. Five-year survival of patients with stage-IIB/III thoracic esophageal squamous cell carcinoma (TESCC) after surgery is 20.0-28.4%, and locoregional lymph-node metastases are the main cause of failure. Several retrospective studies have shown that postoperative radiotherapy (PORT) and postoperative chemoradiotherapy (POCRT) after radical esophagectomy for esophageal carcinoma with positive lymph-node metastases and stage-III disease can decrease locoregional recurrence and increase overall survival (OS). Using intensity-modulated RT, PORT reduces locoregional recurrence further. However, the rate of distant metastases increases to 30.7%. Hence, chemotherapy may be vital for these patients. Therefore, a prospective randomized controlled trial (RCT) is needed to evaluate the value of PORT and concurrent POCRT in comparison with surgery alone (SA) for esophageal cancer.
This will be a phase-II/III RCT. The patients with pathologic stage-IIB/III esophageal squamous cell carcinoma will receive concurrent POCRT or PORT after radical esophagectomy compared with those who have SA. A total of 120 patients in each group will be recruited. POCRT patients will be 50.4 Gy concurrent with paclitaxel (135-150 mg/m) plus cisplatin or nedaplatin (50-75 mg/m) treatment every 28 days. Two cycles will be required for concurrent chemotherapy. The prescription dose will be 54 Gy for PORT. The primary endpoint will be disease-free survival (DFS). The secondary endpoint will be OS. Other pre-specified outcome measures will be the proportion of patients who complete treatment, toxicity, and out-of-field regional recurrence rate between PORT and POCRT.
This prospective RCT will provide high-level evidence for postoperative adjuvant treatment of pathologic stage-IIB/III esophageal squamous cell carcinoma.
clinicaltrials.gov (NCT02279134). Registered on October 26, 2014.
术前放化疗（CRT）后再手术是可切除食管癌患者最常用的治疗方法。然而，相当数量的食管癌患者首先接受手术治疗。新辅助治疗的益处可能仅适用于病理完全缓解的患者，因此需要进行分层研究。由于单独接受手术治疗的 IIB/III 期疾病患者的生存率较差，因此术后治疗具有重要作用。对于 IIB/III 期胸段食管鳞状细胞癌（TESCC）患者，手术后 5 年生存率为 20.0-28.4%，局部淋巴结转移是失败的主要原因。几项回顾性研究表明，根治性食管切除术后对阳性淋巴结转移和 III 期食管癌患者进行术后放疗（PORT）和术后放化疗（POCRT）可降低局部复发率并提高总生存率（OS）。使用调强放疗（IMRT），PORT 进一步降低了局部复发率。然而，远处转移率增加到 30.7%。因此，这些患者可能需要化疗。因此，需要进行前瞻性随机对照试验（RCT），以评估 PORT 和 POCRT 与单独手术（SA）相比在食管癌中的价值。
这将是一项 II/III 期 RCT。病理 IIB/III 期食管鳞状细胞癌患者在根治性食管切除术后接受 POCRT 或 PORT 治疗，与接受 SA 的患者相比。每组将招募 120 名患者。POCRT 患者将在根治性食管切除术后接受紫杉醇（135-150mg/m）联合顺铂或奈达铂（50-75mg/m）治疗，每 28 天一次，共 2 个周期。同步化疗。PORT 的处方剂量为 54Gy。主要终点是无病生存率（DFS）。次要终点是 OS。其他预设的结果指标将是完成治疗的患者比例、毒性和 PORT 与 POCRT 之间的野外区域局部复发率。
这项前瞻性 RCT 将为病理 IIB/III 期食管鳞状细胞癌的术后辅助治疗提供高水平的证据。
clinicaltrials.gov（NCT02279134）。于 2014 年 10 月 26 日注册。
