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, Beijing, 100021, China.
Department 4th of Radiation Oncology, Anyang Cancer Hospital, Anyang, 455000, China.
BMC Cancer. 2019 Apr 29;19(1):397. doi: 10.1186/s12885-019-5544-1.
The importance of definitive radiotherapy for elderly patients with esophageal and esophagogastric-junction cancer is pronounced. However, little is known in terms of the best way to combine radiotherapy with other treatment options. This study aims to compare the efficiency of SIB radiotherapy alone with SIB radiotherapy concurrent and consolidated with S-1 for elderly patients. Comprehensive geriatric assessment is also incorporated in the procedure of treatment.
METHODS/DESIGN: The study is a two arm, open, randomized multicenter Phase III trial with patients over 70 years old with stage IIA-IVB (UICC 2002, IVB only with metastasis to supraclavicular or celiac lymph nodes) squamous cell carcinoma or adenocarcinoma of esophagus or gastroesophageal junction. A total of 300 patients will be randomized using a 1:1 allocation ratio stratified by disease stage and study site. Patients allocated to the SIB arm will receive definitive SIB radiotherapy (95%PTV/PGTV 50.4Gy/59.92Gy/28f) while those randomized to SIB + S-1 arm will receive definitive SIB radiotherapy concurrent and consolidated with S-1. The primary endpoint of the trial is 1-year overall survival. Secondary objectives include progression-free survival, recurrence-free survival (local-regional and distant), disease failure pattern, toxicity profile as well as quality of life. Besides, detailed radiotherapy protocol and quality assurance procedure have been incorporated into this trial.
The proportion of elderly patients in esophageal cancer is now growing, but there is a lack of evidence in term of treatment standard for this group of patients, which is what we aim to obtain through this prospective phase III study.
clinicaltrials.gov NCT02979691 . Registered November 22, 2016.
对于老年食管癌和食管胃交界癌患者，根治性放疗的重要性不言而喻。然而，对于如何将放疗与其他治疗方法相结合，目前知之甚少。本研究旨在比较单纯 SIB 放疗与 SIB 放疗联合和巩固 S-1 治疗老年患者的疗效。综合老年评估也纳入了治疗过程。
方法/设计：这是一项两臂、开放、随机、多中心 III 期临床试验，纳入年龄超过 70 岁、分期为 IIA-IVB 期（UICC 2002 年，仅 IVB 期伴锁骨上或腹腔淋巴结转移）的老年食管或食管胃交界部鳞状细胞癌或腺癌患者。将 300 例患者按疾病分期和研究地点分层，采用 1:1 分配比进行随机分组。SIB 组患者接受根治性 SIB 放疗（95%PTV/PGTV 50.4Gy/59.92Gy/28f），SIB+S-1 组患者接受 SIB 放疗联合和巩固 S-1。试验的主要终点是 1 年总生存率。次要终点包括无进展生存率、无复发生存率（局部区域和远处）、疾病失败模式、毒性谱以及生活质量。此外，本试验还纳入了详细的放疗方案和质量保证程序。
食管癌患者中老年人的比例正在增加，但针对这组患者的治疗标准缺乏证据，这正是我们通过这项前瞻性 III 期研究旨在获得的。
clinicaltrials.gov NCT02979691。注册于 2016 年 11 月 22 日。
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