Study Protocols : Study Protocol of Regorafenib Escalation for Colorectal Cancer (RECC) : A Phase Ⅱ Multicenter Clinical Trial of the Efficacy and Safety of Regorafenib Dose Escalation Therapy as the Third or Fourth Line Therapy for Unresectable/Recurrent Colorectal Cancer
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- SUGIMOTO KIICHI
- Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
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- YAMADA TAKESHI
- Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School
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- ISHIYAMA SHUN
- Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
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- NAKAMURA MASATO
- Aizawa Comprehensive Cancer Center, Aizawa Hospital
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- YOSHIDA YOICHIRO
- Department of Gastroenterological Surgery, Fukuoka University Faculty of Medicine
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- HASEGAWA SUGURU
- Department of Gastroenterological Surgery, Fukuoka University Faculty of Medicine
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- YOKOMIZO HAJIME
- Department of Surgery, Tokyo Women’s Medical University, Medical Center East
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- NARITAKA YOSHIHIKO
- Department of Surgery, Tokyo Women’s Medical University, Medical Center East
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- SAKUYAMA NAOKI
- Department of Surgery, Tobu Chiiki Hospital, Metropolitan Health and Medical Treatment Corporation
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- OCHIAI TAKUMI
- Department of Surgery, Tobu Chiiki Hospital, Metropolitan Health and Medical Treatment Corporation
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- SONODA HIROMICHI
- Department of Surgery, Shiga University of Medical Science
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- TANI MASAJI
- Department of Surgery, Shiga University of Medical Science
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- ENOMOTO MASANOBU
- Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University
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- KATSUMATA KENJI
- Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University
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- YAMAGUCHI TATSURO
- Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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- OHTA RYO
- Department of Surgery, Institute of Gastroenterology, Kawasaki Saiwai Hospital
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- ISHIMARU KEI
- Department of Gastrointestinal Surgery and Surgical Oncology, Ehime University Graduate School of Medicine
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- WATANABE YUJI
- Department of Gastrointestinal Surgery and Surgical Oncology, Ehime University Graduate School of Medicine
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- KODA KEIJI
- Department of Surgery, Teikyo University Chiba Medical Center
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- SAKAMOTO KAZUHIRO
- Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
書誌事項
- タイトル別名
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- Study Protocol of Regorafenib Escalation for Colorectal Cancer (RECC): A Phase II Multicenter Clinical Trial of the Efficacy and Safety of Regorafenib Dose Escalation Therapy as the Third or Fourth Line Therapy for Unresectable/Recurrent Colorectal Cancer
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<p>Objective: Regorafenib (BAY 73-4506) is an oral multikinase inhibitor that has been shown to inhibit various oncogenic stromal receptor tyrosine kinases and intracellular signaling kinase. The aim of the study is to confirm the safety and effectiveness of dose escalation therapy of regorafenib for the third- or fourth- treatments of patients with unresectable and recurrent colorectal cancer.</p><p>Design: This study is designed as a single-arm, prospective, non-randomized, multi-centered open label phase II trial in Japan. The study regimen consists of 28-day cycles with escalated doses of regorafenib (80-160 mg/body on days 1 to 21). This study is a dose-escalation study using a starting dose of 80 mg/day during the first seven days. In case of no adverse events related to the administration after the first seven days of the starting dose, the administration dose will be increased to 120 mg/day on days 8 to 14. The administration dose will then be increased to 160 mg/day on days 15 to 21. Primary end point is progression free survival (PFS); secondary end points include time to treatment failure, response rate, overall survival, the interval between the initial of drug administration and performance status 2, the transition rate to the following line of treatment, the cumulative dose and the incidence of adverse events of grade 3 or higher, and genetic alterations (KRAS mutation/BRAF mutation) in circulating cell-free DNA.</p><p>Conclusions: This study may contribute to determining the efficacy of the escalation of the administration dose in patients with metastatic colorectal cancer.</p>
収録刊行物
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- 順天堂醫事雑誌
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順天堂醫事雑誌 65 (1), 85-91, 2019
順天堂医学会
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詳細情報 詳細情報について
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- CRID
- 1390564238083213568
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- NII論文ID
- 130007631917
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- NII書誌ID
- AA1262207X
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- ISSN
- 21882126
- 21879737
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- NDL書誌ID
- 029709830
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- 本文言語コード
- en
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- データソース種別
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- JaLC
- NDL
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- 使用不可