Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field

Official title

Comparison of Segmentectomy Versus Lobectomy for Early-stage Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field: A Prospective and Multi-center RCT Study

Overview

This study aims to investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field.

Detailed description

Nowadays, the role of segment resection in the treatment of non-small cell lung cancer ≤ 2 cm in the outer third of the lung field has been evaluated in multiple studies. Recently, professor Hisao Asamura released the long-term results of the JCOG0802 project in AATS 2021. Segmentectomy had a higher 5-year overall survival (94.3% vs. 91.1%) than lobectomy (P \< 0.001) for non-small cell lung cancer ≤ 2 cm (CTR \> 0.5) in the outer third of the lung field. However, a substantial portion of lung nodules was not located in the outer third, but the middle third of the lung field. Whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field remains unclear. This randomized controlled trial study aims to investigate whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of the lung field.

Interventions

• Procedure Segmentectomy
  Patients receive segmentectomy
• Procedure Lobectomy
  Patients receive lobectomy

Primary outcome measures

• 5-year Disease-Free Survival [Time frame: From date of the recruitment, assessed up to 60 months]

Secondary outcome measures (4)

• 30-day Morbidity and mortality rates [Time frame: From date of the recruitment, assessed up to 30 days]
• Pulmonary function in the first year after surgery [Time frame: From date of the 3rd, 6th, and 12th month after surgery]
• 3-year Disease-Free-Survival [Time frame: From date of the recruitment, assessed up to 36 months]
• 5-year overall Survival [Time frame: From date of the recruitment, assessed up to 60 months]

Eligibility criteria

Inclusion criteria

• Patient aged 18-75 years old;
• 6 mm ≤ tumor size ≤ 20 mm;
• 0.25 < CTR < 1;
• Center of tumor located in the middle third of the lung field;
• ECOG score of 0,1 or 2;
• Lung function (FEV1 ≥ 1 L and ≥ 70%);
• Both lung segmentectomy and lobectomy could achieve R0 resection;
• No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy;
• No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis;
• Single tumor nodule or the concomitant nodule < microinvasive tumor;
• Written informed consent.

Exclusion criteria

• The tumor nodule is located in right middle lobe;
• A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer);
• Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on;
• A serious mental illness;
• Pregnant and lactating women;
• Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months;
• With the history of cerebral infarction or cerebral hemorrhage within 6 months;
• With the history of sustained systemic corticosteroid therapy within 1 month;
• The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA
• Other unsuitable situations;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University — Nanjing

Publications

• Altorki NK, Wang X, Wigle D, Gu L, Darling G, Ashrafi AS, Landrenau R, Miller D, Liberman M, Jones DR, Keenan R, Conti M, Wright G, Veit LJ, Ramalingam SS, Kamel M, Pass HI, Mitchell JD, Stinchcombe T, Vokes E, Kohman LJ. Perioperative mortality and morbidity after sublobar versus lobar resection for early-stage non-small-cell lung cancer: post-hoc analysis of an international, randomised, phase 3 PMID 30442588
• Nakamura K, Saji H, Nakajima R, Okada M, Asamura H, Shibata T, Nakamura S, Tada H, Tsuboi M. A phase III randomized trial of lobectomy versus limited resection for small-sized peripheral non-small cell lung cancer (JCOG0802/WJOG4607L). Jpn J Clin Oncol. 2010 Mar;40(3):271-4. doi: 10.1093/jjco/hyp156. Epub 2009 Nov 22. PMID 19933688
• Suzuki K, Saji H, Aokage K, Watanabe SI, Okada M, Mizusawa J, Nakajima R, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group; Japan Clinical Oncology Group. Comparison of pulmonary segmentectomy and lobectomy: Safety results of a randomized trial. J Thorac Cardiovasc Surg. 2019 Sep;158(3):895-907. doi: 10.1016/j.jtcvs.2019.03.090. Epub 2019 Apr 9. PMID 31078312
• Wu WB, Xia Y, Pan XL, Wang J, He ZC, Xu J, Wen W, Xu XF, Zhu Q, Chen L. Three-dimensional navigation-guided thoracoscopic combined subsegmentectomy for intersegmental pulmonary nodules. Thorac Cancer. 2019 Jan;10(1):41-46. doi: 10.1111/1759-7714.12897. Epub 2018 Nov 3. PMID 30390378
• Tsutani Y, Miyata Y, Nakayama H, Okumura S, Adachi S, Yoshimura M, Okada M. Appropriate sublobar resection choice for ground glass opacity-dominant clinical stage IA lung adenocarcinoma: wedge resection or segmentectomy. Chest. 2014 Jan;145(1):66-71. doi: 10.1378/chest.13-1094. PMID 24551879
• Wu W, He Z, Xu J, Wen W, Wang J, Zhu Q, Chen L. Anatomical Pulmonary Sublobar Resection Based on Subsegment. Ann Thorac Surg. 2021 Jun;111(6):e447-e450. doi: 10.1016/j.athoracsur.2020.10.083. Epub 2021 Jan 30. PMID 33524360

Identifiers

NCT: NCT04944563 · 2021-SR-164

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗