Clinical Trial Protocol

S-1 for patients with type 4 or large type 3 gastric cancer

https://orcid.org/0000-0003-3759-1214

Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan

Translational Research Support Section, National Cancer Center Hospital East, Kashiwa, Japan

Department of Gastroenterology & Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan

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Izuma Nakayama

*Author for correspondence: Tel.: +81 033 520 0111;

E-mail Address: izuma.nakayama@jfcr.or.jp

Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Japan

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Manabu Ohashi

Department of Gastroenterological Surgery, Cancer Institute Ariak Hospital, Tokyo, Japan

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Junki Mizusawa

Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan

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Hiroshi Kawachi

Department of Pathology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan

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Ryosuke Kita

Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan

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Haruhiko Fukuda

Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan

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Yukinori Kurokawa

https://orcid.org/0000-0002-2883-0132

Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan

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Narikazu Boku

Department of Oncology & General Medicine, IMSUT Hospital, Institute of Medical Science, University of Tokyo, Tokyo, Japan

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Takaki Yoshikawa

Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan

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Masanori Terashima

Division of Gastric Surgery, Shizuoka Cancer Center, Nagaizumi, 411-8777, Japan

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Published Online:26 Oct 2023https://doi.org/10.2217/fon-2023-0605

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Abstract

Macroscopic type 4 and large type 3 gastric cancer, mostly overlapping with scirrhous or linitis plastica type, exhibit a highly invasive nature and show unfavorable prognosis after curative surgery, even with adjuvant chemotherapy. A randomized phase III trial (JCOG0501) failed to demonstrate a survival advantage of neoadjuvant chemotherapy with S-1 plus cisplatin for this population. The current authors initiated a randomized phase II study comparing neoadjuvant chemotherapy with 5-fluorouracil/oxaliplatin/docetaxel versus docetaxel/oxaliplatin/S-1 for type 4 and large type 3 gastric cancer. 76 patients are planned to be enrolled over two years. The primary end point is the proportion of patients with a pathological response (grade 1b or higher) and secondary end points include overall survival and adverse events.

Clinical Trial Registration: jRCTs031230231 (rctportal.niph.go.jp).

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest

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Vol. 19, No. 32

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History

Received 14 July 2023

Accepted 26 September 2023

Published online 26 October 2023

Published in print October 2023

Information

Keywords

Author contributions

All authors meet the criteria for authorship described by the International Committee of Medical Journal Editors and contributed to this work. All authors were involved in the conceptualization of this study. J Mizusawa and H Fukuda were responsible for data curation. I Nakayama, M Ohashi, R Kita, J Mizusawa and H Fukuda conducted the formal analysis, applying statistical or mathematical techniques to analyze the data. I Nakayama, M Ohashi, N Boku, Y Kurokawa, T Yoshikawa, M Terashima and H Fukuda were involved in funding acquisition. T Hashimoto, J Mizusawa and H Fukuda developed the methodology, designing the methods and procedures used in the research. R Kita, J Mizusawa and H Fukuda managed the project administration. N Boku, Y Kurokawa, T Yoshikawa, M Terashima and H Fukuda provided key resources. H Fukuda was responsible for the software. J Mizusawa and H Fukuda provided supervision, overseeing the research team and ensuring the research was conducted appropriately. T Hashimoto and I Nakayama contributed to visualization. T Hashimoto, I Nakayama and M Ohashi drafted the original manuscript. All authors reviewed and edited the paper and approved the submitted version.

Acknowledgments

The authors are grateful to all enrolled patients and investigators for their cooperation in JCOG2204.

Financial disclosure

This study is supported in part by the National Cancer Center Research and Development Funds (2020-J-3, 2023-J-03). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

J Mizusawa has received honoraria from Taiho Pharmaceutical and Chugai Pharmaceutical outside the submitted work; his spouse is an employee of Pfizer Japan Inc. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing disclosure

No writing assistance was used in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

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