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Clinical Trial
. 2025 Oct;43(28):3081-3089.
doi: 10.1200/JCO-25-00610. Epub 2025 Jul 21.

Phase III Study of Mediastinal Lymph Node Dissection for Ground Glass Opacity-Dominant Lung Adenocarcinoma

Yang Zhang  1   2   3 , Bin Qian  4 , Qingping Song  5 , Junjie Ma  6 , Hang Cao  1   2   3 , Chaoqiang Deng  1   2   3 , Shengping Wang  3   7 , Ting Ye  1   2   3 , Jiaqing Xiang  1   2   3 , Yawei Zhang  1   2   3 , Yihua Sun  1   2   3 , Yueren Yan  1   2   3 , Shanbo Zheng  1   2   3 , Haoxuan Wu  1   2   3 , Qingyuan Huang  1   2   3 , Hong Hu  1   2   3 , Yuan Li  3   8 , Fangqiu Fu  1   2   3 , Haiquan Chen  1   2   3
Affiliations
Clinical Trial

Phase III Study of Mediastinal Lymph Node Dissection for Ground Glass Opacity-Dominant Lung Adenocarcinoma

Yang Zhang et al. J Clin Oncol. 2025 Oct.

Abstract

Purpose: Systematic mediastinal lymph node dissection (LND) or sampling is currently recommended for patients with early-stage non-small cell lung cancer. We aimed to investigate whether no mediastinal LND was noninferior to systematic LND in patients with ground glass opacity (GGO)-dominant invasive lung adenocarcinoma.

Methods: We conducted a multicenter, open-label, phase III, noninferiority randomized controlled trial comparing systematic mediastinal LND versus no mediastinal LND in patients with GGO-dominant invasive lung adenocarcinoma, who were predicted to have no lymph node metastasis on the basis of criteria established in our previous trial. The primary end point was 3-year disease-free survival. An interim analysis was planned upon enrollment of 300 patients, with predefined termination criteria if no mediastinal lymph node metastasis is detected and life-threatening complications occur in the systematic LND arm. This trial is registered on ClinicalTrials.gov (ECTOP-1009, identifier: NCT04527419).

Results: Interim analysis of 302 patients revealed no lymph node metastasis in either study arm. The no LND arm had significantly reduced surgery duration (mean, 74 minutes v 109 minutes; P < .001), blood loss (mean, 44 mL v 82 mL; P = .033), and postoperative hospital stay (mean, 3.9 days v 4.5 days; P = .002). Complications observed in the systematic LND arm included chylothorax in one patient (0.7%) and intraoperative massive bleeding because of superior vena cava injury in one patient (0.7%). No lymphadenectomy-related complications occurred in the no LND arm.

Conclusion: On the basis of interim findings and the principle of nonmaleficence, the trial should be terminated. Systematic mediastinal LND should no longer be recommended for patients with GGO-dominant lung adenocarcinoma.

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Conflict of interest statement

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

No potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
Trial profile. AAH, atypical adenomatous hyperplasia; AIS, adenocarcinoma in situ; LND, lymph node dissection; MIA, minimally invasive adenocarcinoma.
FIG 2.
FIG 2.
Kaplan-Meier curves of (A) disease-free survival and (B) overall survival, stratified by mediastinal LND or not. LND, lymph node dissection.
See this image and copyright information in PMC

References

    1. http://www.nccn.org NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer (version 3.2025)
    1. Allen MS, Darling GE, Pechet TT, et al. Morbidity and mortality of major pulmonary resections in patients with early-stage lung cancer: Initial results of the randomized, prospective ACOSOG Z0030 trial. Ann Thorac Surg. 2006;81:1013–1020. - PubMed
    1. Cho HJ, Kim DK, Lee GD, et al. Chylothorax complicating pulmonary resection for lung cancer: Effective management and pleurodesis. Ann Thorac Surg. 2014;97:408–413. - PubMed
    1. Han H, Chen H. Selective lymph node dissection in early-stage non-small cell lung cancer. J Thorac Dis. 2017;9:2102–2107. - PMC - PubMed
    1. Jiang C, Zhang Y, Fu F, et al. A shift in paradigm: Selective lymph node dissection for minimizing oversurgery in early stage lung cancer. J Thorac Oncol. 2024;19:25–35. - PubMed

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