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