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Not yet recruiting NCT06646770

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

No phase Interventional Non-Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Segmentectomy, Lobectomy.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Segmentectomy Versus Lobectomy in Clinical T1c Non-Small Cell Lung Cancer: A Non-Inferiority Trial

Overview

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

  • Procedure Segmentectomy
    Pulmonary anatomic segmentectomy with mediastinal nodal dissection via VATS, RATS or open approach.
  • Procedure Lobectomy
    Pulmonary lobectomy with mediastinal nodal dissection via VATS, RATS or open approach.

Primary outcome measures

  • Survival Survival [Time frame: 5 years]
Secondary outcome measures (2)
  • Complication rate associated with surgery [Time frame: 90 days]
  • Mortality rate [Time frame: 90 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty — Istanbul

Identifiers

NCT: NCT06646770 · 2501

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗