A phase III randomized controlled trial comparing surgery plus adjuvant chemotherapy with preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for locally recurrent rectal cancer: Japan Clinical Oncology Group study JCOG1801 (RC-SURVIVE study)

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  • Tomohiro Kadota
    JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan
  • Yuichiro Tsukada
    Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan
  • Masaaki Ito
    Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan
  • Hiroshi Katayama
    JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan
  • Junki Mizusawa
    JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan
  • Naoki Nakamura
    Department of Radiation Oncology and Particle Therapy, National Cancer Center Hospital East, Kashiwa, Japan
  • Yoshinori Ito
    Department of Radiation Oncology, Showa University School of Medicine, Tokyo, Japan
  • Hideaki Bando
    Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan
  • Masahiko Ando
    Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan
  • Hiroaki Onaya
    Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya, Japan
  • Haruhiko Fukuda
    JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan
  • Yukihide Kanemitsu
    Department of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan

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<jats:title>Abstract</jats:title><jats:p>A randomized phase III trial was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy compared to the standard treatment, i.e. surgery plus adjuvant chemotherapy, for locally recurrent rectal cancer in local relapse-free survival. In all, 110 patients from 43 Japanese institutions will be recruited over a period of 6 years. Eligible patients would be registered and randomly assigned to each group with an allocation ratio of 1:1. The primary endpoint is local relapse-free survival. The secondary endpoints are overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions) and quality of life after surgery. This trial has been registered at the Japan Registry of Clinical Trial: jRCTs031190076 [https://jrct.niph.go.jp/latest-detail/jRCTs031190076] and ClinicalTrials.gov: NCT04288999 [https://clinicaltrials.gov/ct2/show/NCT04288999].</jats:p>

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