SEgmentectomy Versus Lobectomy in T1C Non-Small Cell Lung Cancer (SELTIC)
NCT ID: NCT06646770
Last Updated: 2024-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
400 participants
INTERVENTIONAL
2025-01-02
2030-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Segmentectomy
Pulmonary anatomic segmentectomy with mediastinal nodal dissection
Segmentectomy
Pulmonary anatomic segmentectomy with mediastinal nodal dissection via VATS, RATS or open approach.
Lobectomy
Pulmonary lobectomy with mediastinal nodal dissection
Lobectomy
Pulmonary lobectomy with mediastinal nodal dissection via VATS, RATS or open approach.
Interventions
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Segmentectomy
Pulmonary anatomic segmentectomy with mediastinal nodal dissection via VATS, RATS or open approach.
Lobectomy
Pulmonary lobectomy with mediastinal nodal dissection via VATS, RATS or open approach.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Istanbul University - Cerrahpasa
OTHER
Responsible Party
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Akif Turna
Professor
Principal Investigators
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Akif Turna, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
Locations
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Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2501
Identifier Type: -
Identifier Source: org_study_id
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