Localized colorectal cancer database integrating 4 randomized controlled trials; (JCOG2310A)

Kozo Kataoka; Akira Ouchi; Yusuke Suwa; Hidekazu Hirano; Toshifumi Yamaguchi; Yasuyuki Takamizawa; Marie Hanaoka; Kenta Iguchi; Shogen Boku; Ken Nagata; Taiji Koyama; Yasuhiro Shimada; Masafumi Inomata; Yusuke Sano; Junki Mizusawa; Tetsuya Hamaguchi; Yasumasa Takii; Shunsuke Tsukamoto; Atsuo Takashima; Yukihide Kanemitsu; JCOG Colorectal Cancer Study Group

doi:10.1016/j.ejso.2024.108354

Localized colorectal cancer database integrating 4 randomized controlled trials; (JCOG2310A)

Eur J Surg Oncol. 2024 Apr 18;50(6):108354. doi: 10.1016/j.ejso.2024.108354. Online ahead of print.

Authors

Kozo Kataoka¹, Akira Ouchi², Yusuke Suwa³, Hidekazu Hirano⁴, Toshifumi Yamaguchi⁵, Yasuyuki Takamizawa⁶, Marie Hanaoka⁷, Kenta Iguchi⁸, Shogen Boku⁹, Ken Nagata¹⁰, Taiji Koyama¹¹, Yasuhiro Shimada¹², Masafumi Inomata¹³, Yusuke Sano¹⁴, Junki Mizusawa¹⁴, Tetsuya Hamaguchi¹⁵, Yasumasa Takii¹⁶, Shunsuke Tsukamoto⁶, Atsuo Takashima⁴, Yukihide Kanemitsu¹⁷; JCOG Colorectal Cancer Study Group

Affiliations

¹ Division of Lower GI, Department of Gastroenterological Surgery, Hyogo Medical University, Hyogo, Japan.
² Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan.
³ Department of Surgery, Gastroenterological Center Yokohama City University Medical Center, Yokohama, Japan.
⁴ Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
⁵ Cancer Chemotherapy Center, Osaka Medical and Pharmaceutical University Hospital, Osaka, Japan.
⁶ Department of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan.
⁷ Department of Gastrointestinal Surgery, Tokyo Medical and Dental University, Tokyo, Japan.
⁸ Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
⁹ Cancer Treatment Center, Kansai Medical University Hospital, Osaka, Japan.
¹⁰ Department of Surgery, National Defense Medical College, Saitama, Japan.
¹¹ Department of Medical Oncology and Hematology, Kobe University Hospital and Graduate School of Medicine, Hyogo, Japan.
¹² Clinical Oncology Division, Kochi Health Sciences Center, Kochi, Japan.
¹³ Department of Gastroenterological and Pediatric Surgery, Oita University Hospital, Oita, Japan.
¹⁴ Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
¹⁵ Department of Gastroenterological Oncology, Saitama Medical University International Medical Center, Hidaka, Japan.
¹⁶ Department of Surgery, Niigata Cancer Center Hospital, Niigata, Japan.
¹⁷ Department of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan. Electronic address: ykanemit@ncc.go.jp.

PMID: 38657376
DOI: 10.1016/j.ejso.2024.108354

Abstract

Although phase III randomized controlled trials (RCTs) represent the most robust statistical approach for answering clinical questions, they require massive expenditures in terms of time, labor, and funding. Ancillary and supplementary analyses using RCTs are sometimes conducted as alternative approaches to answering clinical questions, but the available integrated databases of RCTs are limited. In this background, the Colorectal Cancer Study Group (CCSG) of the Japan Clinical Oncology Group (JCOG) established a database of ancillary studies integrating four phase III RCTs (JCOG0212, JCOG0404, JCOG0910 and JCOG1006) conducted by the CCSG to investigate specific clinicopathological factors in pStage II/III colorectal cancer (JCOG2310A). This database will be updated by adding another clinical trial data and accelerating several analyses that are clinically relevant in the management of localized colorectal cancer. This study describes the details of this database and planned and ongoing analyses as an initiative of JCOG cOlorectal Young investigators (JOY).