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.

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.

• Authors: 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
• Journal: BMC cancer (BMC Cancer) Vol. 23 Issue 1 Pg. 450 (May 17 2023) ISSN: 1471-2407 [Electronic] England
• PMID: 37198556 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: © 2023. The Author(s).

Chemical References

• Irinotecan
• Tegafur
• Oxaliplatin
• Leucovorin
• Fluorouracil

Topics

• Humans
• Irinotecan (therapeutic use)
• Tegafur
• Oxaliplatin
• Leucovorin
• Neoadjuvant Therapy (methods)
• Rectal Neoplasms (drug therapy, pathology)
• Treatment Outcome
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Chemoradiotherapy (methods)
• Fluorouracil (therapeutic use)
• Neoplasm Staging
• Clinical Trials, Phase II as Topic