Preoperative chemoradiotherapy using tegafur/uracil, oral leucovorin, and irinotecan (TEGAFIRI) followed by oxaliplatin-based chemotherapy as total neoadjuvant therapy for locally advanced rectal cancer: the study protocol for a phase II trial
Shinya Abe,
Kazushige Kawai,
Hiroaki Nozawa,
Kazuhito Sasaki,
Koji Murono,
Shigenobu Emoto,
Yuichiro Yokoyama,
Hiroyuki Matsuzaki,
Yuzo Nagai,
Yuichiro Yoshioka,
Takahide Shinagawa,
Hirofumi Sonoda,
Yoko Yamamoto,
Koji Oba,
Soichiro Ishihara
Affiliations
Shinya Abe
Department of Surgical Oncology, Graduate School of Medicine, University of Tokyo
Kazushige Kawai
Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Hiroaki Nozawa
Department of Surgical Oncology, Graduate School of Medicine, University of Tokyo
Kazuhito Sasaki
Department of Surgical Oncology, Graduate School of Medicine, University of Tokyo
Koji Murono
Department of Surgical Oncology, Graduate School of Medicine, University of Tokyo
Shigenobu Emoto
Department of Surgical Oncology, Graduate School of Medicine, University of Tokyo
Yuichiro Yokoyama
Department of Surgical Oncology, Graduate School of Medicine, University of Tokyo
Hiroyuki Matsuzaki
Department of Surgical Oncology, Graduate School of Medicine, University of Tokyo
Yuzo Nagai
Department of Surgical Oncology, Graduate School of Medicine, University of Tokyo
Yuichiro Yoshioka
Department of Surgical Oncology, Graduate School of Medicine, University of Tokyo
Takahide Shinagawa
Department of Surgical Oncology, Graduate School of Medicine, University of Tokyo
Hirofumi Sonoda
Department of Surgical Oncology, Graduate School of Medicine, University of Tokyo
Yoko Yamamoto
Department of Surgical Oncology, Graduate School of Medicine, University of Tokyo
Koji Oba
Department of Biostatistics, Graduate School of Medicine, The University of Tokyo
Soichiro Ishihara
Department of Surgical Oncology, Graduate School of Medicine, University of Tokyo
Abstract Background Total neoadjuvant therapy (TNT) is a novel treatment strategy that is an alternative to preoperative chemoradiotherapy (CRT) for locally advanced rectal cancer (LARC). However, an optimal protocol for TNT has not yet been established. The present study will be an open-label, single-arm, single-center trial to develop a new protocol. Methods Thirty LARC patients at high risk of distant metastasis will receive CRT consisting of long-course radiation, concurrent with tegafur/uracil, oral leucovorin, irinotecan (TEGAFIRI), followed by mFOLFOX-6 or CAPOX before undergoing surgery. Discussion Since previous findings showed a high percentage of grade 3–4 adverse events with the TEGAFIRI regimen for CRT and TNT, the primary outcome of this study will be safety and feasibility. Our regimen for CRT consists of the biweekly administration of irinotecan for good patient compliance. The novel combination approach of this treatment may improve the long-term outcomes of LARC. Trial Registration Japan Registry of Clinical Trials jRCTs031210660.
