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Article History

Received: 3 June 2020

Accepted: 2 July 2020

First Online: 13 July 2020

Ethics approval and consent to participate

: This study is being conducted in accordance with the principles expressed in the Declaration of Helsinki, Japanese Ethical Guidelines for Medical and Health Research Involving Human Subjects and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. The study protocol was approved by the JCOG Protocol Review Committee in December 2017 and by the Institutional Review Board of National Cancer Center Hospital on February 9th, 2018. Written informed consent has been obtained from all enrolled participants. At the time of submission (June 2020), a total of 21 institutions are participating in this trial. The participating institutions are as follows: Hokkaido University Hospital, Asahikawa Medical University Hospital, Sapporo Medical University School of Medicine, University of Tsukuba, Saitama Medical University International Medical Center, Saitama Medical University, National Cancer Center Hospital, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital, Keio University Hospital, The University of Tokyo Hospital, Niigata Cancer Center Hospital, Toyama Prefectural Central Hospital, Shinshu University School of Medicine, Shizuoka Cancer Center, Nagoya University School of Medicine, Kyoto University Hospital, Osaka International Cancer Institute, Faculty of Medicine, Fukuoka University, Kyushu University Hospital, Kumamoto University Hospital and National Hospital Organization Kagoshima Medical Center.

: Not applicable.

: Dr. Namikawa has received honoraria from Ono Pharmaceutical, Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis Pharmaceutical, Toray Industries, Takara Bio, Eisai, and Chugai Pharmaceutical, unrelated to the submitted work.Dr. Tsutsumida has received honoraria from Ono Pharmaceutical, Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis Pharmaceutical, unrelated to the submitted work.Dr. Takahashi has received honoraria from Ono Pharmaceutical, Bristol-Myers Squibb, Merck Sharp & Dohme, and Novartis Pharmaceutical, unrelated to the submitted work.Dr. Yamazaki has received honoraria from Ono Pharmaceutical, Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis Pharmaceutical, Takeda Pharmaceutical, and Chugai Pharmaceutical, unrelated to the submitted work.