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NCT Number: NCT06646770

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

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

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

Istanbul, 34198, Turkey (Türkiye)

Location contact

Akif Turna, MD, PhD

CONTACT

[email protected]

+905052581581

Gizem Özçıbık Işık, MD

SUB_INVESTIGATOR

Hasan Volkan Kara, MD

SUB_INVESTIGATOR

Melek Agkoc, MD

SUB_INVESTIGATOR

Melek Ağkoç, MD

CONTACT

[email protected]

+905348108485

Zahid Haciyev, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Segmentectomy

Procedure

Pulmonary anatomic segmentectomy with mediastinal nodal dissection via VATS, RATS or open approach.

Lobectomy

Procedure

Pulmonary lobectomy with mediastinal nodal dissection via VATS, RATS or open approach.

Primary outcomes

  1. Survival Survival

    Time frame: 5 years

    Overall and recurrence free survival

Secondary outcomes

  1. Complication rate associated with surgery

    Time frame: 90 days

  2. Mortality rate

    Time frame: 90 days

    mortality rate associated with surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Akif Turna, MD, PhD

CONTACT

[email protected]

+905052581581

Melek Ağkoç, MD

CONTACT

[email protected]

+905348108485

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Acronym: SELTIC

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Oct 17, 2024
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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