A randomized phase III trial of postoperative surveillance for pathological stage II and IIIA non-small cell lung cancer (JCOG2012, PHOENIX)

Author:

Tane Kenta1,Shiono Satoshi2,Wakabayashi Masashi3,Kataoka Tomoko3,Mitome Noriko3,Fukuda Haruhiko3,Aokage Keiju1,Watanabe Shun-ichi4,

Affiliation:

1. Division of Thoracic Surgery, National Cancer Center Hospital East , 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577 , Japan

2. Department of Surgery II, Faculty of Medicine , 2-2-2 Iida-Nishi, Yamagatashi, Yamagata 990-9585 , Japan

3. JCOG Data Center/Operations Office, National Cancer Center Hospital , 5-1-1 Tsukiji, Chuoku, Tokyo, 104-0045 , Japan

4. Division of Thoracic Surgery, National Cancer Center Hospital , 5-1-1 Tsukiji, Chuoku, Tokyo, 104-0045 , Japan

Abstract

Abstract The goal of postoperative surveillance following non-small cell lung cancer surgery is to detect recurrence and second primary malignancies while curative treatment is still possible. Although several guidelines recommend that patients have computed tomography (CT) scans every 6 months for the first 2 years after resection, then once a year, there is no evidence that it is effective for survival, especially in locally advanced non-small cell lung cancer. In October 2022, we launched a multi-institutional, randomized controlled phase III trial for pathological stage II and IIIA non-small cell lung cancer patients to confirm the non-inferiority of less intensive surveillance with less frequent CT scans versus standard surveillance in terms of overall survival. The primary endpoint is overall survival. We intend to enroll 1100 patients from 45 institutions over 4 years. The trial has been registered in the Japan Registry of Clinical Trials under the code jRCT1030220361 (https://jrct.niph.go.jp/latest-detail/jRCT1030220361).

Funder

National Cancer Center Research and Development Fund

Japan Agency for Medical Research and Development

Publisher

Oxford University Press (OUP)

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