SEgmentectomy Versus Lobectomy in T1C Non-Small Cell Lung Cancer (SELTIC)

Not Applicable

Not yet recruiting

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT06646770
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17
• Study Start: 2025-01-02
• Primary Completion: 2030-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Survival Survival	5 years	Overall and recurrence free survival

Secondary Outcome Measures

Name	Time	Method
Complication rate associated with surgery	90 days
Mortality rate	90 days	mortality rate associated with surgery

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty; 🇹🇷 Istanbul, Turkey