110
Participants
Start Date
October 1, 2019
Primary Completion Date
August 31, 2025
Study Completion Date
October 31, 2028
Chemotherapy
"Adjuvant chemotherapy: CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV~CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14)~mFOLOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours.~Capecitabine: 2000 mg/m2/day, twice daily, days 1-14~5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours"
Preoperative radiotherapy
"Preoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy~Preoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr)"
Procedure
"Surgery for Locally Recurrent Rectal Cancer (LRRC) will be performed within 42 days from registration for the patients in arm A, and between days 56 and 98 from the completion of the preCRT for the patients in arm B.~Appropriate surgical procedure will be performed to achieve R0 resection, such as low anterior resection, super low anterior resection, intersphincteric resection, Hartmann procedure, rectal amputation, pelvic exenteration, tumor resection, or lateral lymph node dissection"
RECRUITING
Chiba Cancer Center, Chiba
RECRUITING
Gifu University School of Medicine, Gifu
NOT_YET_RECRUITING
Saitama Medical University International Medical Center, Hidaka
NOT_YET_RECRUITING
Kansai Medical University Hospital, Hirakata
RECRUITING
Hiroshima City Asa Citizens Hospital, Hiroshima
RECRUITING
Hiroshima City Hospital, Hiroshima
RECRUITING
Shimane University Faculty of Medicine, Izumo
RECRUITING
Ishikawa Prefectural Central Hospital, Kanazawa
RECRUITING
National Cancer Center Hospital East, Kashiwa
RECRUITING
Saitama Medical Center, Saitama Medical University, Kawagoe
RECRUITING
Kochi Health Sciences Center, Kochi
RECRUITING
Kumamoto University Hospital, Kumamoto
RECRUITING
Kurashiki Central Hospital, Kurashiki
RECRUITING
Kurume University School of Medicine, Kurume
RECRUITING
National Hospital Organization Shikoku Cancer Center, Matsuyama
RECRUITING
Kyorin University Faculty of Medicine, Mitaka
NOT_YET_RECRUITING
Iwate Medical University, Morioka
NOT_YET_RECRUITING
Nagoya University Graduate School of Medicine, Nagoya
RECRUITING
Niigata Cancer Center Hospital, Niigata
RECRUITING
Hyogo College of Medicine, Nishinomiya
RECRUITING
Okayama Saiseikai General Hospital, Okayama
RECRUITING
National Hospital Organization Osaka National Hospital, Osaka
RECRUITING
Osaka City General Hospital, Osaka
RECRUITING
Ogaki Municipal Hospital, Ōgaki
RECRUITING
Gunma Prefectural Cancer Center, Ōta-ku
RECRUITING
Saitama Cancer Center, Saitama
RECRUITING
Sapporo-Kosei General Hospital, Sapporo
RECRUITING
Miyagi Cancer Center, Sendai
RECRUITING
Shizuoka Cancer Center, Shizuoka
RECRUITING
Osaka University Graduate School of Medicine, Suita
RECRUITING
Suita Municipal Hospital, Suita
RECRUITING
Osaka Medical College, Takatsuki
RECRUITING
National Defense Medical College, Tokorozawa
RECRUITING
National Cancer Center Hospital, Tokyo
RECRUITING
Toho University Ohashi Medical Center, Tokyo
NOT_YET_RECRUITING
Toho University Omori Medical Center, Tokyo
RECRUITING
Tokyo Medical and Dental University Hospital, Tokyo
RECRUITING
Tokyo Medical University Hospital, Tokyo
RECRUITING
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Tokyo
RECRUITING
Tochigi Cancer Center, Utsunomiya
RECRUITING
Yamagata Prefectural Central Hospital, Yamagata
RECRUITING
Kanagawa Cancer Center, Yokohama
RECRUITING
Saiseikai Yokohama-shi Nanbu Hospital, Yokohama
RECRUITING
Yokohama City University Medical Center, Yokohama
RECRUITING
Oita University Faculty of Medicine, Yufu
Collaborators (1)
Japan Clinical Oncology Group
OTHER
Japan Agency for Medical Research and Development
OTHER_GOV
National Cancer Center Hospital East
OTHER