Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, T1c, Segmentectomy, Lobectomy
Brief summary
The goal of this clinical trial is to investigate the role of segmentectomy in clinical T1c (2-3 cm) non-small cell lung cancer (NSCLC). The main questions we aim to answer are: 1. Is segmentectomy non-inferior to lobectomy in cT1c NSCLC in terms of overall and recurrence free survival? 2. What are the mortality and morbidity rates of segmentectomy compared to lobectomy? Researchers will compare segmentectomy and lobectomy in terms of overall and recurrence free survival. Participants will: * Undergo either pulmonary lobectomy or segmentectomy with mediastinal nodal dissection * Be followed up with a chest CT in every 3 months in first year, every 6 months in second year and every year for following 3 years
Interventions
PROCEDURESegmentectomy
Pulmonary anatomic segmentectomy with mediastinal nodal dissection via VATS, RATS or open approach.
PROCEDURELobectomy
Pulmonary lobectomy with mediastinal nodal dissection via VATS, RATS or open approach.
Sponsors
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical T1c NSCLC * Parenchymal nodule \>2 cm in diameter * Parenchymal nodule ≤3 cm in diameter * Consolidation / Tumor Rate (CTR) ≥ 0.50 * Definitive pathological diagnosis of NSCLC preoperative or intraoperatively * No evidence of distant metastasis * No evidence of N2 disease * Adequate pulmonary functions for lobectomy or segmentectomy
Exclusion criteria
* Pure GGO lesions * Pathologic diagnosis other than NSCLC * Technically not suitable for simple or complex segmentectomy, or lobectomy * Evidence of distant metastasis * Pathologically confirmed N2 or N3 disease * Major comorbidity that precludes surgery * Intraoperative mediastinal nodal dissection of less than 3 lymph node stations * Prior malignancy in five years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival Survival | 5 years | Overall and recurrence free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate associated with surgery | 90 days | — |
| Mortality rate | 90 days | mortality rate associated with surgery |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAkif Turna, MD, PhD
Backup ContactMelek Ağkoç, MD
Outcome results
None listed