Shimokawa, Mototsugu
Nosaki, Kaname
Seto, Takashi
Ohashi, Kadoaki
Morise, Masahiro
Horinouchi, Hidehito
Sakakibara, Jun
Murakami, Haruyasu
Yano, Seiji
Satouchi, Miyako
Matsumoto, Shingo
Goto, Koichi
Yoh, Kiyotaka
Funding for this research was provided by:
Practical Research for Innovation Cancer Control from Japan Agency for Medical Research and Development, AMED (JP19ck0106294)
Article History
Received: 4 December 2019
Accepted: 2 March 2020
First Online: 30 March 2020
Ethics approval and consent to participate
: The study was approved by the IRB at the National Hospital Organization Kyushu Cancer Center on 7 March 2018 (*21, protocol version 1.0), Okayama University Hospital on 15 May 2018 (M300206), Hyogo Cancer Center on 9 May 2018 (HCC227), Nagoya University Hospital on 10 September 2018 (302007), Shizuoka Cancer Center on 24 May 2018 (no reference), Kanazawa University Hospital on 13 June 2018 (9016), National Cancer Center Hospital on 23 May 2018 (T4552), National Cancer Center Hospital East on 23 May 2018 (K0715), and Hokkaido University Hospital on 22 May 2018 (H30–5). Any protocol modification will be approved by the IRBs before its implementation. This study will be conducted in compliance with the study protocol, the Helsinki declaration and the Ministerial Ordinance on Good Clinical Practice (GCP) for Drugs. All participants will give written informed consent. Central ethical approval has been confirmed from the IRB at the National Hospital Organization Kyushu Cancer Center (ref approval no. *21), and we will not begin recruiting at other centers in the trial until local ethical approval has been obtained. Written informed consent will be provided by patients before enrollment. The informed consent documentation is are available from the corresponding author on request.
: Not applicable.
: KN and SM have received Honoraria from Pfizer Japan. TS has received Honoraria and research grants from Pfizer Japan. HM has received personal fees from Pfizer Japan. KG has received Honoraria and research funding from Pfizer Japan. KY has received research funding from Pfizer Japan. All other authors declare that they have no conflicts of interest.