Clinical trial · Interventional
Comparison of Lobectomy and Segmentectomy for cT1aN0M0 Peripheral NSCLC
A Phase III Randomized Trial of Anatomical Segmentectomy Versus Lobectomy by Minimal Incision for Stage IA Peripheral Non-Small Cell Lung Cancer (≤ 2cm)
- 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)
Anatomic segmentectomy may be a less invasive type of surgery than lobectomy for cT1aN0M0 peripheral NSCLC and may retain more pulmonary function. It is not yet known whether anatomic segmentectomy is non-inferior to lobectomy in treating stage IA non-small cell lung cancer. The aim of this study is to investigate whether the outcome of anatomic segmentectomy is similar to lobectomy for peripheral stage IA (≤ 2cm)non-small cell lung cancer (NSCLC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| segmentectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- segmentectomy
- description
- Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS.
- interventionNames
- Procedure: segmentectomy
- type
- ACTIVE_COMPARATOR
- label
- lobectomy
- description
- Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS.
- interventionNames
- Procedure: segmentectomy
Primary outcomes (1)
- measure
- Relapse-free survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-70y 2. Preoperative criteria: ⅰ)Center of tumor is located in the outer third of the lung field, and the maximal diameter ≤ 2 cm(including coronal, traverse and sagittal view) confirmed by 1mm thin layer contrast-enhanced CT scan. ⅱ)no hilar and mediastinal lymph node metastasis verified by mediastinoscope/EBUS. 3. Intraoperative criteria: ⅰ)Adenocarcinama or squamous cell carcinoma of lung confirmed by frozen section. ⅱ)Lobectomy, single segmentectomy or combined segmentectomy is feasible. ⅲ)Confirmation of N0 status by frozen section examination of nodal levels 10 and 13 for segmentectomy, and 10 for lobectomy. 4. ECOG performance status 0-2. 5. No other malignancy within the past 3 years( except for well prognostic malignancy such as basal cell carcinoma of skin, superficial bladder cancer, or carcinoma in situ of the cervix). 6. No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed). 7. No prior chemotherapy or radiation therapy. 8. Lobectomy is tolerated. 9. Sufficient organ functions. 10. Written informed consent. Exclusion Criteria: 1. Active bacterial or fungous infection. 2. Simultaneous or metachronous (within the past 5 years) multiple cancers. 3. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema, and can not tolerate lobectomy. 4. Psychosis. 5. Uncontrollable diabetes mellitus. 6. History of severe heart disease. 7. The maximal diameter of GGO≤5mm. 8. N1, N2, or M1a is confirmed postoperatively. 9. Postoperative adjuvant therapy (chemotherapy ,radiotherapy or targeted therapy). 10. Other types of lung cancer such as small cell lung cancer, large cell lung cancer, etc. 11. Confirmation of benign disease by postoperative pathologic examination. 12. Lesion located in the middle lobe.
References
Publications (0)
Data not yet available