A multicenter phase III study comparing Simultaneous Integrated Boost (SIB) radiotherapy concurrent and consolidated with S-1 versus SIB alone in elderly patients with esophageal and esophagogastric cancer – the 3JECROG P-01 study protocol
Chen Li,
Xiaomin Wang,
Xin Wang,
Chun Han,
Ping Wang,
Qingsong Pang,
Junqiang Chen,
Xinchen Sun,
Lan Wang,
Wencheng Zhang,
Yu Lin,
Xiaolin Ge,
Zongmei Zhou,
Wenjie Ni,
Xiao Chang,
Jun Liang,
Lei Deng,
Wenqing Wang,
Yidian Zhao,
Zefen Xiao
Affiliations
Chen Li
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
Xiaomin Wang
Department 4th of Radiation Oncology, Anyang Cancer Hospital
Xin Wang
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
Chun Han
Department of Radiation Oncology, the Fourth Hospital of Hebei Medical University
Ping Wang
Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital/National Clinical Research Center for Cancer
Qingsong Pang
Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital/National Clinical Research Center for Cancer
Junqiang Chen
Department of Radiation Oncology, Fujian Cancer Hospital/Fujian Medical University Cancer Hospital
Xinchen Sun
Department of Radiation Oncology, the First Affiliated Hospital of Nanjing Medical University
Lan Wang
Department of Radiation Oncology, the Fourth Hospital of Hebei Medical University
Wencheng Zhang
Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital/National Clinical Research Center for Cancer
Yu Lin
Department of Radiation Oncology, Fujian Cancer Hospital/Fujian Medical University Cancer Hospital
Xiaolin Ge
Department of Radiation Oncology, the First Affiliated Hospital of Nanjing Medical University
Zongmei Zhou
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
Wenjie Ni
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
Xiao Chang
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
Jun Liang
Department of Radiation Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Lei Deng
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
Wenqing Wang
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
Yidian Zhao
Department 4th of Radiation Oncology, Anyang Cancer Hospital
Zefen Xiao
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
Abstract Background 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. Discussion 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. Trial registration clinicaltrials.gov NCT02979691. Registered November 22, 2016.