A multi-institutional randomized phase III trial comparing postoperative radiotherapy to observation after adjuvant chemotherapy in patients with pathological N2 Stage III non-small cell lung cancer: Japan Clinical Oncology Group Study JCOG1916 (J-PORT study)

Ryo Shimoyama, Kazuo Nakagawa, Satoshi Ishikura, Masashi Wakabayashi, Tomonari Sasaki, Hiroshige Yoshioka, Tadayoshi Hashimoto, Tomoko Kataoka, Haruhiko Fukuda, Shun Ichi Watanabe

Research output: Contribution to journalArticlepeer-review

Abstract

The standard treatment for pathological N2 Stage III non-small cell lung cancer with negative surgical margins in Japan is cisplatin-based adjuvant chemotherapy. However, recent studies suggest that the addition of thoracic radiotherapy after adjuvant chemotherapy prolongs survival. While thoracic radiotherapy is considered to prolong survival by improving locoregional control, it is known to increase radiation-induced adverse events. We began a randomized controlled trial in January 2021 in Japan to confirm the superiority of radiotherapy over observation after adjuvant chemotherapy in pathological N2 Stage III non-small cell lung cancer patients with negative surgical margins. We aim to accrue 330 patients from 47 institutions over 5 years. The primary endpoint is relapse-free survival; the secondary endpoints are overall survival, proportion of patients completing radiotherapy in the radiotherapy arm, early adverse events, late adverse events in the radiotherapy arm, serious adverse events and local recurrence.

Original languageEnglish
Pages (from-to)999-1003
Number of pages5
JournalJapanese journal of clinical oncology
Volume51
Issue number6
DOIs
Publication statusPublished - May 28 2021

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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