Cancer Communications (Oct 2024)
Concurrent chemoradiotherapyof different radiation doses and different irradiation fields for locally advanced thoracic esophageal squamous cell carcinoma: A randomized, multicenter, phase III clinical trial
- Jian Zhang,
- Minghao Li,
- Kaixian Zhang,
- Anping Zheng,
- Guang Li,
- Wei Huang,
- Shaoshui Chen,
- Xiangming Chen,
- Xiaomin Li,
- Yanxing Sheng,
- Xinchen Sun,
- Liping Liu,
- Xiaowei Liu,
- Jie Li,
- Jun Wang,
- Hong Ge,
- Shucheng Ye,
- Qingsong Pang,
- Xianwen Zhang,
- Shengbin Dai,
- Richard Yu,
- Wendong Gu,
- Mingming Dai,
- Gaowa Siqin,
- Yunwei Han,
- Xiaolin Ge,
- Xin Yuan,
- Yongjing Yang,
- Haiwen Zhu,
- Juan Pu,
- Lihua Dong,
- Xiangdong Sun,
- Jundong Zhou,
- Weidong Mao,
- Fei Gao,
- Haiqun Lin,
- Heyi Gong,
- Tao Zhou,
- Zhenjiang Li,
- Hongsheng Li,
- Zhongtang Wang,
- Baosheng Li
Affiliations
- Jian Zhang
- Department of Oncology Central Hospital Affiliated to Shandong First Medical University Jinan Shandong P. R. China
- Minghao Li
- Department of Radiation Oncology Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences Jinan Shandong P. R. China
- Kaixian Zhang
- Department of Oncology Tengzhou Central People's Hospital Tengzhou Shandong P. R. China
- Anping Zheng
- Department of Radiation Oncology Anyang Tumor Hospital Anyang Henan P. R. China
- Guang Li
- Department of Radiation Oncology the First Hospital of China Medical University Shenyang Liaoning P. R. China
- Wei Huang
- Department of Radiation Oncology Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences Jinan Shandong P. R. China
- Shaoshui Chen
- Department of Oncology Binzhou Medical University Hospital Binzhou Shandong P. R. China
- Xiangming Chen
- Department of Oncology Taian Central Hospital Taian Shandong P. R. China
- Xiaomin Li
- Department of Radiation Oncology Shanxi Province Cancer Hospital Taiyuan Shanxi P. R. China
- Yanxing Sheng
- Department of Oncology Liaocheng People's Hospital Liaocheng Shandong P. R. China
- Xinchen Sun
- Department of Radiation Oncology the First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu P. R. China
- Liping Liu
- Department of Oncology Jining First People′s Hospital Jining Shandong P. R. China
- Xiaowei Liu
- Department of Oncology the Affiliated Hospital of Jining Medical University Jining Shandong P. R. China
- Jie Li
- Department of Radiation Oncology Shanxi Province Cancer Hospital Taiyuan Shanxi P. R. China
- Jun Wang
- Department of Radiation Oncology the Fourth Hospital of Hebei Medical University, Hebei Clinical Research Center for Radiation Oncology Shijiazhuang Hebei P. R. China
- Hong Ge
- Department of Radiation Oncology the Affiliated Cancer Hospital of Zhengzhou University Zhengzhou Henan P. R. China
- Shucheng Ye
- Department of Oncology the Affiliated Hospital of Jining Medical University Jining Shandong P. R. China
- Qingsong Pang
- 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
- Xianwen Zhang
- Department of Oncology Subei People's Hospital of Jiangsu Province Yangzhou Jiangsu P. R. China
- Shengbin Dai
- Department of Oncology Taizhou People's Hospital of Jiangsu Province Taizhou Zhejiang P. R. China
- Richard Yu
- Department of Radiation Oncology the Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia P. R. China
- Wendong Gu
- Department of Radiation Oncology the Third Affiliated Hospital of Soochow University Changzhou Jiangsu P. R. China
- Mingming Dai
- Department of Radiation Oncology the First Affiliated Hospital of Xiamen University Xiamen Fujian P. R. China
- Gaowa Siqin
- Department of Radiation Oncology Inner Mongolia Cancer Hospital Hohhot Inner Mongolia P. R. China
- Yunwei Han
- Department of Oncology the Affiliated Hospital of Southwest Medical University Luzhou Sichuan P. R. China
- Xiaolin Ge
- Department of Radiation Oncology the First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu P. R. China
- Xin Yuan
- Department of Oncology the Affiliated Hospital of Yangzhou University Yangzhou Jiangsu P. R. China
- Yongjing Yang
- Department of Radiation Oncology Jilin Cancer Hospital Changchun Jilin P. R. China
- Haiwen Zhu
- Department of Radiation Oncology Yancheng Third People's Hospital Yancheng Jiangsu P. R. China
- Juan Pu
- Department of Radiation Oncology Lianshui County People's Hospital Huaian Jiangsu P. R. China
- Lihua Dong
- Department of Radiation Oncology the First Bethune Hospital of Jilin University Changchun Jilin P. R. China
- Xiangdong Sun
- Department of Radiation Oncology Jinling Hospital Nanjing University Medical School Nanjing Jiangsu P. R. China
- Jundong Zhou
- Department of Radiation Oncology the Affiliated Suzhou Hospital of Nanjing Medical University Suzhou Jiangsu P. R. China
- Weidong Mao
- Department of Oncology Jiangyin People's Hospital Affiliated to Nantong University Jiangyin Jiangsu P. R.China
- Fei Gao
- Department of Radiation Oncology the Affiliated Taixing People's Hospital of Yangzhou University Taixing Jiangsu P. R. China
- Haiqun Lin
- Department of Oncology the Second Hospital of Shandong University Jinan Shandong P. R.China
- Heyi Gong
- Department of Radiation Oncology Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences Jinan Shandong P. R. China
- Tao Zhou
- Department of Radiation Oncology Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences Jinan Shandong P. R. China
- Zhenjiang Li
- Department of Radiation Oncology Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences Jinan Shandong P. R. China
- Hongsheng Li
- Department of Radiation Oncology Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences Jinan Shandong P. R. China
- Zhongtang Wang
- Department of Radiation Oncology Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences Jinan Shandong P. R. China
- Baosheng Li
- Department of Radiation Oncology Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences Jinan Shandong P. R. China
- DOI
- https://doi.org/10.1002/cac2.12601
- Journal volume & issue
-
Vol. 44,
no. 10
pp. 1173 – 1188
Abstract
Abstract Background Concurrent 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. Methods This 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. Results The 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. Conclusions IFI 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.
Keywords
- clinical trial
- concurrent chemoradiotherapy
- elective nodal radiation
- esophageal squamous cell carcinoma
- high dose radiation
- involved field radiation
