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

Istanbul University - Cerrahpasa (IUC)

Status: Not yet enrolling

Conditions: Non-Small Cell Lung Cancer

Treatments: Procedure: Segmentectomy; Procedure: Lobectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06646770

2501

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Segmentectomy

Experimental group

Description:

Pulmonary anatomic segmentectomy with mediastinal nodal dissection

Treatment:

Procedure: Segmentectomy

Lobectomy

Active Comparator group

Description:

Pulmonary lobectomy with mediastinal nodal dissection

Treatment:

Procedure: Lobectomy