Segmentectomy vs Lobectomy

NCT ID: NCT06180239

Last Updated: 2023-12-22

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer Stage I Surgery

Keywords

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segmentectomy lobectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Single Segmentectomy group

patients underwent single segment resection,

No interventions assigned to this group

Lobectomy group

Patients underwent lobectomy

No interventions assigned to this group

Multiple segmentectomy group

patients underwent multiple segments resection,

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regina Elena Cancer Institute

OTHER

Sponsor Role collaborator

Istituto Europeo di Oncologia

OTHER

Sponsor Role collaborator

University of Pisa

OTHER

Sponsor Role collaborator

A.O.U. Città della Salute e della Scienza - Molinette Hospital

OTHER

Sponsor Role collaborator

Azienda Ospedaliera "Sant'Andrea"

OTHER

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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CHIAPPETTA MARCO

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Marco Chiappetta

Roma, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 28881918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35461558 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11269480 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17720401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31078312 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10036605 (View on PubMed)

Other Identifiers

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6146

Identifier Type: -

Identifier Source: org_study_id