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

October 16, 2024 updated by: Akif Turna, Istanbul University - Cerrahpasa (IUC)

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34198
        • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hasan Volkan Kara, MD
        • Sub-Investigator:
          • Melek Agkoc, MD
        • Sub-Investigator:
          • Gizem Özçıbık Işık, MD
        • Sub-Investigator:
          • Zahid Haciyev, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Segmentectomy
Pulmonary anatomic segmentectomy with mediastinal nodal dissection
Procedure: Segmentectomy
Pulmonary anatomic segmentectomy with mediastinal nodal dissection via VATS, RATS or open approach.
Active Comparator: Lobectomy
Pulmonary lobectomy with mediastinal nodal dissection
Procedure: Lobectomy
Pulmonary lobectomy with mediastinal nodal dissection via VATS, RATS or open approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Survival
Time Frame: 5 years
Overall and recurrence free survival
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate associated with surgery
Time Frame: 90 days
90 days
Mortality rate
Time Frame: 90 days
mortality rate associated with surgery
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Akif Turna, MD, PhD, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 2, 2025

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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