Segmentectomy vs Lobectomy

NCT06180239 | Unknown

• 1 other identifier: 6146
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Actual indications for stage Ia NSCLC patients suggest lobectomy and lymphadenectomy. On the other hand, recent studies reported non-inferiority of segmentectomy in case of nodule \< 2cm or with ground glass appearance at computed tomography. However, most of these studies did not report specifical analysis on kind of segmentectomy (single or multiple) and kind of lobectomy. Moreover, a specific study on solid nodules only is still missing. For these reasons, the effectiveness of segmentectomy instead lobectomy for every kind of segment or tumor is still to be defined. Aim of this study is to analyze survival outcome in patients underwent single or multiple segmentectomy compared to lobectomy in stage I non small cell lung cancer.

Conditions

Non-small Cell Lung Cancer Stage I; Surgery

Keywords

segmentectomy; lobectomy

Outcome Measures

Primary Outcomes (1)

• disease free survival

  Time between surgery and recurrence appearance

  1 YEAR

Study Arms (3)

Single Segmentectomy group

patients underwent single segment resection,

Lobectomy group

Patients underwent lobectomy

Multiple segmentectomy group

patients underwent multiple segments resection,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected with NSCLC solid or part solid at the CT scan or PET CT study. These patients underwent anatomical resection with lymphoadenectomy and radical intent

You may qualify if:

• Adenocarcinoma or squamous cell carcinoma
• cStage cIA with or without nodal upstaging
• lymphoadenectomy
• age \> 18 years old
• Radical resection
• anatomical resection (lobectomy or segmentectomy)
• PET CT done

You may not qualify if:

• Nodal or distant metastasis confirmed before surgery
• Pure solid GGO
• Follow up \< 12 months
• Bilobectomy/pneumonectomy
• Trans fissure tumor
• Multiple lung tumors

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Regina Elena Cancer Institute: collaborator
• Istituto Europeo di Oncologia: collaborator
• University of Pisa: collaborator
• A.O.U. Città della Salute e della Scienza - Molinette Hospital: collaborator
• Azienda Ospedaliera "Sant'Andrea": collaborator

Study Sites (1)

Marco Chiappetta

Roma, 00168, Italy

Location

Related Publications (6)

• Postmus PE, Kerr KM, Oudkerk M, Senan S, Waller DA, Vansteenkiste J, Escriu C, Peters S; ESMO Guidelines Committee. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv1-iv21. doi: 10.1093/annonc/mdx222. No abstract available.

  PMID: 28881918 BACKGROUND

• Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617. doi: 10.1016/S0140-6736(21)02333-3.

  PMID: 35461558 BACKGROUND

• Okada M, Yoshikawa K, Hatta T, Tsubota N. Is segmentectomy with lymph node assessment an alternative to lobectomy for non-small cell lung cancer of 2 cm or smaller? Ann Thorac Surg. 2001 Mar;71(3):956-60; discussion 961. doi: 10.1016/s0003-4975(00)02223-2.

  PMID: 11269480 BACKGROUND

• Schuchert MJ, Pettiford BL, Keeley S, D'Amato TA, Kilic A, Close J, Pennathur A, Santos R, Fernando HC, Landreneau JR, Luketich JD, Landreneau RJ. Anatomic segmentectomy in the treatment of stage I non-small cell lung cancer. Ann Thorac Surg. 2007 Sep;84(3):926-32; discussion 932-3. doi: 10.1016/j.athoracsur.2007.05.007.

  PMID: 17720401 BACKGROUND

• Suzuki K, Saji H, Aokage K, Watanabe SI, Okada M, Mizusawa J, Nakajima R, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group; Japan Clinical Oncology Group. Comparison of pulmonary segmentectomy and lobectomy: Safety results of a randomized trial. J Thorac Cardiovasc Surg. 2019 Sep;158(3):895-907. doi: 10.1016/j.jtcvs.2019.03.090. Epub 2019 Apr 9.

  PMID: 31078312 BACKGROUND

• Wiley JL, Balster RL. Antipunishment activity of diazepam in rats trained to discriminate diazepam from vehicle. Exp Clin Psychopharmacol. 1999 Feb;7(1):13-9.

  PMID: 10036605 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 22, 2023
• Study Start: January 1, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)