SEgmentectomy Versus Lobectomy in T1C Non-Small Cell Lung Cancer (SELTIC)
SELTIC
Segmentectomy Versus Lobectomy in Clinical T1c Non-Small Cell Lung Cancer: A Non-Inferiority Trial
1 other identifier
interventional
400
1 country
1
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:
- 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable nonsmall-cell-lung-cancer
Started Jan 2025
Longer than P75 for not_applicable nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2024
CompletedFirst Posted
Study publicly available on registry
October 17, 2024
CompletedStudy Start
First participant enrolled
January 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
October 17, 2024
October 1, 2024
5 years
October 16, 2024
October 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival Survival
Overall and recurrence free survival
5 years
Secondary Outcomes (2)
Complication rate associated with surgery
90 days
Mortality rate
90 days
Study Arms (2)
Segmentectomy
EXPERIMENTALPulmonary anatomic segmentectomy with mediastinal nodal dissection
Lobectomy
ACTIVE COMPARATORPulmonary lobectomy with mediastinal nodal dissection
Interventions
Pulmonary anatomic segmentectomy with mediastinal nodal dissection via VATS, RATS or open approach.
Pulmonary lobectomy with mediastinal nodal dissection via VATS, RATS or open approach.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
Istanbul, 34198, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Akif Turna, MD, PhD
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 16, 2024
First Posted
October 17, 2024
Study Start
January 2, 2025
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2030
Last Updated
October 17, 2024
Record last verified: 2024-10