Spots Global Cancer Trial Database for Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer
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Trial Identification
Brief Title: Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer
Official Title: JCOG1801: 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 (RC-SURVIVE Study)
Study ID: NCT04288999
Conditions
Study Description
Brief Summary: JCOG1801 is a randomized phase III trial which was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for local relapse-free survival over standard treatment, i.e. surgery plus adjuvant chemotherapy, for previously non-irradiated locally recurrent rectal cancer.
Detailed Description: 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.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Chiba Cancer Center, Chiba, , Japan
Gifu University School of Medicine, Gifu, , Japan
Saitama Medical University International Medical Center, Hidaka, , Japan
Kansai Medical University Hospital, Hirakata, , Japan
Hiroshima City Asa Citizens Hospital, Hiroshima, , Japan
Hiroshima City Hospital, Hiroshima, , Japan
Shimane University Faculty of Medicine, Izumo, , Japan
Ishikawa Prefectural Central Hospital, Kanazawa, , Japan
National Cancer Center Hospital East, Kashiwa, , Japan
Saitama Medical Center, Saitama Medical University, Kawagoe, , Japan
Kochi Health Sciences Center, Kochi, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Kurashiki Central Hospital, Kurashiki, , Japan
Kurume University School of Medicine, Kurume, , Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama, , Japan
Kyorin University Faculty of Medicine, Mitaka, , Japan
Iwate Medical University, Morioka, , Japan
Nagoya University Graduate School of Medicine, Nagoya, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Hyogo College of Medicine, Nishinomiya, , Japan
Okayama Saiseikai General Hospital, Okayama, , Japan
National Hospital Organization Osaka National Hospital, Osaka, , Japan
Osaka City General Hospital, Osaka, , Japan
Saitama Cancer Center, Saitama, , Japan
Sapporo-Kosei General Hospital, Sapporo, , Japan
Miyagi Cancer Center, Sendai, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
Osaka University Graduate School of Medicine, Suita, , Japan
Suita Municipal Hospital, Suita, , Japan
Osaka Medical College, Takatsuki, , Japan
National Defense Medical College, Tokorozawa, , Japan
National Cancer Center Hospital, Tokyo, , Japan
Toho University Ohashi Medical Center, Tokyo, , Japan
Toho University Omori Medical Center, Tokyo, , Japan
Tokyo Medical and Dental University Hospital, Tokyo, , Japan
Tokyo Medical University Hospital, Tokyo, , Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Tokyo, , Japan
Tochigi Cancer Center, Utsunomiya, , Japan
Yamagata Prefectural Central Hospital, Yamagata, , Japan
Kanagawa Cancer Center, Yokohama, , Japan
Saiseikai Yokohama-shi Nanbu Hospital, Yokohama, , Japan
Yokohama City University Medical Center, Yokohama, , Japan
Oita University Faculty of Medicine, Yufu, , Japan
Ogaki Municipal Hospital, Ōgaki, , Japan
Gunma Prefectural Cancer Center, Ōta, , Japan
Contact Details
Name: Masaaki Ito, MD, PhD
Affiliation: National Cancer Center Hospital East
Role: PRINCIPAL_INVESTIGATOR
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