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A non-randomized confirmatory trial of segmentectomy for clinical T1N0 lung cancer with dominant ground glass opacity based on thin-section computed tomography (JCOG1211)

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Abstract

Introduction

Lobectomy has been the standard surgery for even stage I lung cancer since the validity of limited resection for stage I lung cancer was denied by the randomized study reported in 1995. The aim of this non-randomized confirmatory going on since September 2013 is to confirm the efficacy of a segmentectomy for clinical T1N0 lung cancer with dominant ground glass opacity based on thin-slice computed tomography.

Method

A total of 390 patients from 42 Japanese institutions are recruited within 4 years. The primary endpoint of this study is a 5-year relapse-free survival in all of the patients who undergo a segmentectomy for a lung nodule. The secondary endpoints are overall survival, annual relapse-free survival, disease-free survival, proportion of local relapse, postoperative pulmonary function, proportion of segmentectomy completion, proportion of R0 resection completion by segmentectomy, adverse events, and serious adverse events. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000011819 (http://www.umin.ac.jp/ctr/).

Results

Patient’s accrual has been already finished in November, 2015 and the primary analysis will be performed in 2021.

Conclusion

This study is one of the pivotal trial of lung segmentectomy for early lung cancer. The result will provide a clear evidence for our daily clinics and will be possible contribution to preserving pulmonary function for lung cancer patients.

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Acknowledgements

This research was supported by the National Cancer Center Research and Development Fund (26-A-4) and the Practical Research for Innovative Cancer Control (15ck0106051h002) from the Japan Agency for Medical Research and Development, AMED.

Participating institutions (from North to South)

National Hospital Organization Sendai Medical Center, Tohoku University Hospital, Yamagata Prefectural Central Hospital, Ibaraki Prefectural Central Hospital & Cancer Center, Tochigi Cancer Center, Gunma Prefectural Cancer Center, Saitama Cancer Center, National Cancer Center Hospital East, Chiba Cancer Center, Chiba University Graduate School of Medicine, National Cancer Center Hospital, Kyorin University Faculty of Medicine, Tokyo Medical University Hospital, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Juntendo University Hospital, St. Marianna University School of Medicine, Kanagawa Cancer Center, Yokohama Municipal Citizen’s Hospital, Yokohama City University Medical Center, Niigata Cancer Center Hospital, Kanazawa University School of Medicine, Shizuoka Cancer Center, Aichi Cancer Center Hospital, Nagoya University School of Medicine, Kyoto University Hospital, Osaka University Graduate School of Medicine, Kinki University Hospital Faculty of Medicine, Osaka Prefectural Hospital Organization Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka Prefectural Hospital Organization Osaka Prefectural medical Center for Respiratory and Allergic Diseases, National Hospital Organization Kinki-chuo Chest Medical Center, Osaka City General Hospital, Hyogo Cancer Center, Kurashiki Central Hospital, Okayama University Hospital, National Hospital Organization Kure Medical Center Chugoku Cancer Center, Hiroshima University Hospital, National Hospital Organization Shikoku Cancer Center, National Kyushu Cancer Center, School of Medicine Fukuoka University, Nagasaki University Hospital, Kumamoto University Medical School, Kumamoto Chuo Hospital, Oita University Faculty of Medicine, and National Hospital Organization Okinawa National Hospital.

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Authors and Affiliations

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

    Keiju Aokage

  2. Department of Chest Surgery, St. Marianna University School of Medicine, Kanagawa, Japan

    Hisashi Saji

  3. Division of General Thoracic Surgery, Juntendo University Hospital, Tokyo, Japan

    Kenji Suzuki

  4. JCOG Data Center/Operations Office, National Cancer Center, Tokyo, Japan

    Tomonori Mizutani, Hiroshi Katayama & Taro Shibata

  5. Division of Thoracic Surgery, National Cancer Center Hospital, Tokyo, Japan

    Syunichi Watanabe

  6. Division of Thoracic Surgery, Keio University School of Medicine, Tokyo, Japan

    Hisao Asamura

Authors
  1. Keiju Aokage
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  2. Hisashi Saji
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  3. Kenji Suzuki
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  4. Tomonori Mizutani
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  5. Hiroshi Katayama
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  6. Taro Shibata
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  7. Syunichi Watanabe
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  8. Hisao Asamura
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Consortia

on behalf of the Lung Cancer Surgical Study Group of the Japan Clinical Oncology Group

Corresponding author

Correspondence to Keiju Aokage.

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None declared.

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Aokage, K., Saji, H., Suzuki, K. et al. A non-randomized confirmatory trial of segmentectomy for clinical T1N0 lung cancer with dominant ground glass opacity based on thin-section computed tomography (JCOG1211). Gen Thorac Cardiovasc Surg 65, 267–272 (2017). https://doi.org/10.1007/s11748-016-0741-1

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  • DOI: https://doi.org/10.1007/s11748-016-0741-1

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