Clinical trial · Interventional
Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field
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
NCT04944563CI-TRIAL-00057548recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lobectomy | Procedure | — | UNRESOLVED |
| Segmentectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Segmentectomy
- description
- Patients receive segmentectomy
- interventionNames
- Procedure: Segmentectomy
- type
- ACTIVE_COMPARATOR
- label
- Lobectomy
- description
- Patients receive lobectomy
- interventionNames
- Procedure: Lobectomy
Primary outcomes (1)
- measure
- 5-year Disease-Free Survival
- timeFrame
- From date of the recruitment, assessed up to 60 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient aged 18-75 years old; 2. 6 mm ≤ tumor size ≤ 20 mm; 3. 0.25 \< CTR \< 1; 4. Center of tumor located in the middle third of the lung field; 5. ECOG score of 0,1 or 2; 6. Lung function (FEV1 ≥ 1 L and ≥ 70%); 7. Both lung segmentectomy and lobectomy could achieve R0 resection; 8. No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy; 9. No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis; 10. Single tumor nodule or the concomitant nodule \< microinvasive tumor; 11. Written informed consent. Exclusion Criteria: 1. The tumor nodule is located in right middle lobe; 2. A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer); 3. Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on; 4. A serious mental illness; 5. Pregnant and lactating women; 6. Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months; 7. With the history of cerebral infarction or cerebral hemorrhage within 6 months; 8. With the history of sustained systemic corticosteroid therapy within 1 month; 9. The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA 10. Other unsuitable situations;
References
Publications (6)
- BACKGROUNDAltorki 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 trial (CALGB/Alliance 140503). Lancet Respir Med. 2018 Dec;6(12):915-924. doi: 10.1016/S2213-2600(18)30411-9. Epub 2018 Nov 12. PMID 30442588
- BACKGROUNDNakamura 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
- BACKGROUNDSuzuki 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
- BACKGROUNDWu 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
- BACKGROUNDTsutani 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
- BACKGROUNDWu 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.