Single-arm confirmatory trial of postoperative concurrent chemoradiotherapy using intensity modulated radiation therapy for patients with high-risk uterine cervical cancer: Japan Clinical Oncology Group study (JCOG1402)

Naoya Murakami, Fumiaki Isohashi, Yoko Hasumi, Takahiro Kasamatsu, Hiroyuki Okamoto, Kenichi Nakamura, Taro Shibata, Yoshinori Ito, Satoshi Ishikura, Yasumasa Nishimura, Nobuo Yaegashi, Takafumi Toita

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

A single-arm multi-center confirmatory trial was started in Japan to confirm the efficacy and safety of post-radical hysterectomy concurrent chemoradiotherapy using intensity-modulated radiation therapy (IMRT-CCRT) for patients with high-risk uterine cervical cancer, for which the current standard treatment is CCRT using three-dimensional conformal radiation therapy (3DCRT-CCRT). This study began in April 2017 and a total of 220 patients will be accrued from 44 institutions within 3.5 years. The primary endpoint is 3-year relapse-free survival. The secondary endpoints are overall survival, loco-regional relapse-free survival, proportion of late lower gastrointestinal adverse events greater than or equal to grade 3, proportion of lower edema limbs, adverse events, and serious adverse events. This trial was registered at the Japan Registry of Clinical Trials as jRCTs031180194 (https://jrct.niph.go.jp/).

Original languageEnglish
Pages (from-to)881-885
Number of pages5
JournalJapanese journal of clinical oncology
Volume49
Issue number9
DOIs
Publication statusPublished - 2019 Oct 15

Keywords

  • clinical trials
  • concurrent chemoradiotherapy
  • intensity-modulated radiation therapy
  • phase III
  • radical hysterectomy
  • uterine cervical cancer

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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