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Brief Title: Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection
Official Title: A Randomized, Double-Blind, Phase III Study Comparing FTD/TPI Therapy Versus Placebo in Patients Who Are Positive for Blood Circulating Tumor DNA After Curative Resection of Colorectal Cancer
Study ID: NCT04457297
Brief Summary: This trial is a randomized, double-blind, multinational Phase III study to evaluate the efficacy and safety of preemptive treatment with FTD/TPI compared with administration of placebo as follow-up, which is the standard of care, in patients who underwent curative resection of colorectal cancer and then tested positive for ctDNA.
Detailed Description:
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Shikoku Cancer Center, Matsuyama, Ehime, Japan
University of Fukui Hospital, Yoshida, Fukui, Japan
Hospital of the University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan
Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Sano Hospital, Kobe, Hyogo, Japan
University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan
Kanazawa University Hospital, Kanazawa, Ishikawa, Japan
Kagawa University Hospital, Kita, Kagawa, Japan
St. Marianna University School of Medicine Hospital, Kawasaki, Kanagawa, Japan
Yokohama City University Medical Center, Yokohama, Kanagawa, Japan
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
Tohoku University Hospital, Sendai, Miyagi, Japan
Aizawa Hospital, Matsumoto, Nagano, Japan
University of the Ryukyus Hospital, Nakagami, Okinawa, Japan
Kansai Medical University Hospital, Hirakata, Osaka, Japan
Osaka University Hospital, Suita, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital, Takatsuki, Osaka, Japan
Shimane Prefectural Central Hospital, Izumo, Shimane, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyo, Tokyo, Japan
National Cancer Center Hospital, Chuo, Tokyo, Japan
Cancer Institute Hospital Of JFCR, Koto, Tokyo, Japan
Kyorin University Hospital, Mitaka, Tokyo, Japan
Chiba Cancer Center, Chiba, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Kyushu University Hospital, Fukuoka, , Japan
Gifu University Hospital, Gifu, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
University Hospital, Kyoto Prefectural Univercity of Medicine, Kyoto, , Japan
Kyoto-Katsura Hospital, Kyoto, , Japan
Okayama University Hospital, Okayama, , Japan
National Hospital Organization Osaka National Hospital, Osaka, , Japan
Saitama Cancer Center, Saitama, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
Toyama University Hospital, Toyama, , Japan
National Taiwan University Hospital, Taipei, , Taiwan