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Concurrent chemoradiotherapyof different radiation doses and different irradiation fields for locally advanced thoracic esophageal squamous cell carcinoma: A randomized, multicenter, phase III clinical trial

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机构: [1]Department of Oncology, Central Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, P. R. China [2]Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, P. R. China [3]Department of Oncology, Tengzhou Central People’s Hospital, Tengzhou, Shandong, P. R. China [4]Department of Radiation Oncology, Anyang Tumor Hospital, Anyang, Henan, P. R. China [5]Department of Radiation Oncology, the First Hospital of China Medical University, Shenyang, Liaoning, P. R. China [6]Department of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, P. R. China [7]Department of Oncology, Taian Central Hospital, Taian, Shandong, P. R. China [8]Department of Radiation Oncology, Shanxi Province Cancer Hospital, Taiyuan, Shanxi, P. R. China [9]Department of Oncology, Liaocheng People’s Hospital, Liaocheng, Shandong, P. R. China [10]Department of Radiation Oncology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, P. R. China [11]Department of Oncology, Jining First People′s Hospital, Jining, Shandong, P. R. China [12]Department of Oncology, the Affiliated Hospital of Jining Medical University, Jining, Shandong, P. R. China [13]Department of Radiation Oncology, the Fourth Hospital of Hebei Medical University, Hebei Clinical Research Center for Radiation Oncology, Shijiazhuang, Hebei, P. R. China [14]Department of Radiation Oncology, the Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China [15]Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin’s Clinical Research Center for Cancer, Tianjin, P. R. China [16]Department of Oncology, Subei People’s Hospital of Jiangsu Province, Yangzhou, Jiangsu, P. R. China [17]Department of Oncology, Taizhou People’s Hospital of Jiangsu Province, Taizhou, Zhejiang, P. R. China [18]Department of Radiation Oncology, the Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, P. R. China [19]Department of Radiation Oncology, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, P. R. China [20]Department of Radiation Oncology, the First Affiliated Hospital of Xiamen University, Xiamen, Fujian, P. R. China [21]Department of Radiation Oncology, Inner Mongolia Cancer Hospital, Hohhot, Inner Mongolia, P. R. China [22]Department of Oncology, the Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, P. R. China [23]Department of Oncology, the Affiliated Hospital of Yangzhou University, Yangzhou, Jiangsu, P. R. China [24]Department of Radiation Oncology, Jilin Cancer Hospital, Changchun, Jilin, P. R. China [25]Department of Radiation Oncology, Yancheng Third People’s Hospital, Yancheng, Jiangsu, P. R. China [26]Department of Radiation Oncology, Lianshui County People’s Hospital, Huaian, Jiangsu, P. R. China [27]Department of Radiation Oncology, the First Bethune Hospital of Jilin University, Changchun, Jilin, P. R. China [28]Department of Radiation Oncology, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, P. R. China [29]Department of Radiation Oncology, the Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou, Jiangsu, P. R. China [30]Department of Oncology, Jiangyin People’s Hospital Affiliated to Nantong University, Jiangyin, Jiangsu, P. R.China [31]Department of Radiation Oncology, the Affiliated Taixing People’s Hospital of Yangzhou University, Taixing, Jiangsu, P. R. China [32]Department of Oncology, the Second Hospital of Shandong University, Jinan, Shandong, P. R.China
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关键词: clinical trial concurrent chemoradiotherapy elective nodal radiation esophageal squamous cell carcinoma high dose radiation involved field radiation overall survival standard dose radiation

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BackgroundConcurrent chemoradiotherapy (CCRT) is the standard treatment for locally advanced esophageal squamous cell carcinoma (ESCC). However, the optimal radiotherapy regimen, particularly in terms of total dose and planned range of irradiation field, remains unclear. This phase III clinical trial aimed to compare the survival benefits between different radiation doses and different target fields.MethodsThis trial compared two aspects of radiation treatment, total dose and field, using a two-by-two factorial design. The high-dose (HD) group received 59.4 Gy radiation, and the standard-dose (SD) group received 50.4 Gy. The involved field irradiation (IFI) group and elective nodal irradiation (ENI) group adopted different irradiation ranges. The participants were assigned to one of the four groups (HD+ENI, HD+IFI, SD+ENI and SD+IFI). The primary endpoint was overall survival (OS), and the secondary endpoints included progression-free survival (PFS). The synergy indexwas used to measure the interaction effect between dose and field.ResultsThe interaction analysis did not reveal significant synergistic effects between the dose and irradiation field. In comparison to the target field, patients in IFI or ENI showed similar OS (hazard ratio [HR] = 0.99, 95% CI: 0.80-1.23, p = 0.930) and PFS (HR = 1.02, 95% CI: 0.82-1.25). The HD treatment did not show significantly prolonged OS compared with SD (HR = 0.90, 95% CI: 0.72-1.11, p = 0.318), but it suggested improved PFS (25.2 months to 18.0 months). Among the four groups, the HD+IFI group presented the best survival, while the SD+IFI group had the worst prognosis. No significant difference in the occurrence of severe adverse events was found in dose or field comparisons.ConclusionsIFI demonstrated similar treatment efficacy to ENI in CCRT of ESCC. The HD demonstrated improved PFS, but did not significantly improve OS. The dose escalation based on IFI (HD+IFI) showed better therapeutic efficacy than the current recommendation (SD+ENI) and is worth further validation.

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大类 | 1 区 医学
小类 | 2 区 肿瘤学
最新[2023]版:
大类 | 1 区 医学
小类 | 2 区 肿瘤学
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Q1 ONCOLOGY
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Q1 ONCOLOGY

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第一作者机构: [1]Department of Oncology, Central Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, P. R. China [2]Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, P. R. China
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