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Trial Title:
SEgmentectomy Versus Lobectomy in T1C Non-Small Cell Lung Cancer (SELTIC)
NCT ID:
NCT06646770
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Non-Small Cell Lung Cancer
T1c
Segmentectomy
Lobectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Segmentectomy
Description:
Pulmonary anatomic segmentectomy with mediastinal nodal dissection via VATS, RATS or open
approach.
Arm group label:
Segmentectomy
Intervention type:
Procedure
Intervention name:
Lobectomy
Description:
Pulmonary lobectomy with mediastinal nodal dissection via VATS, RATS or open approach.
Arm group label:
Lobectomy
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
Address:
City:
Istanbul
Zip:
34198
Country:
Turkey
Contact:
Last name:
Akif Turna, MD, PhD
Phone:
+905052581581
Email:
aturna@iuc.edu.tr
Contact backup:
Last name:
Melek Ağkoç, MD
Phone:
+905348108485
Email:
melek.agkoc1@gmail.com
Investigator:
Last name:
Hasan Volkan Kara, MD
Email:
Sub-Investigator
Investigator:
Last name:
Melek Agkoc, MD
Email:
Sub-Investigator
Investigator:
Last name:
Gizem Özçıbık Işık, MD
Email:
Sub-Investigator
Investigator:
Last name:
Zahid Haciyev, MD
Email:
Sub-Investigator
Start date:
January 2, 2025
Completion date:
January 2030
Lead sponsor:
Agency:
Istanbul University - Cerrahpasa (IUC)
Agency class:
Other
Source:
Istanbul University - Cerrahpasa (IUC)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06646770
