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Article History

Received: 28 July 2021

Accepted: 4 October 2021

First Online: 15 October 2021

Declarations

:

: This study is being conducted in accordance with the principles expressed in the Declaration of Helsinki, Clinical Trials Act (Act No. 16 of April 14, 2017) and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. The study protocol was approved by the JCOG Protocol Review Committee on April 24th, 2020 and by the National Cancer Center Hospital Certified Review Board on June 25th, 2020 (CRB3180008). Written informed consent has been obtained from all enrolled participants. At the time of submission (May 2021), a total of 51 institutions are participating in this trial. The participating institutions are as follows: Hokkaido University Hospital, Nakamura Memorial Hospital, Sapporo Medical University, Hirosaki University Hospital, Iwate Medical University, Tohoku University Hospital, Yamagata University Hospital, Faculty of Medicine, University of Tsukuba, Jichi Medical University Hospital, Dokkyo Medical University Hospital, Gunma University Hospital, Saitama Cancer Center, Saitama Medical University International Medical Center, Chiba University, Graduate School of Medicine, National Cancer Center Hospital, Nihon University Itabashi Hospital, Kyorin University Faculty of Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo Women’s Medical University, Keio University Hospital, Showa University Hospital, Tokyo Medical and Dental University Hospital, The University of Tokyo Hospital, Tokai University Hospital, Juntendo University Hospital, Nippon Medical School Hospital, Yokohama City University Hospital, Kitasato University School of Medicine, Niigata University Medical and Dental Hospital, University of Yamanashi Faculty of Medicine University Hospital, Hamamatsu University Hospital, Shizuoka Cancer Center, Nagoya University School of Medicine, Fujita Health University, University Hospital Kyoto Prefectural University of Medicine, Kyoto University Hospital, Osaka University Graduate School of Medicine, Osaka International Cancer Institute, Kobe University Graduate School of Medicine, Kobe City Medical Center General Hospital, Nara Medical University Hospital, Okayama University Hospital, Hiroshima University Hospital, Ehime University Hospital, Kurume University Hospital, Kyushu University Hospital, Saga University Hospital, Nagasaki University Hospital, Kumamoto University Medical School, Oita University Faculty of Medicine, and Kagoshima University Hospital.

: Not applicable.

: All authors declare no competing interests in relation to this study protocol.