Segmentectomy vs Lobectomy

NCT06180239 — Unknown, 800 participants, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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Different Segmentectomy vs Lobectomy Comparison in NSCLC

Registry	NCT06180239
Status	Unknown
Study type	Observational
Enrollment	800 (Estimated)
Sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other); collaborators: Regina Elena Cancer Institute, Istituto Europeo di Oncologia, University of Pisa, A.O.U. Città della Salute e della Scienza - Molinette Hospital, Azienda Ospedaliera "Sant'Andrea"
Conditions	Non-small Cell Lung Cancer Stage I, Surgery
Dates	start 2017-01-01, primary completion 2022-12-31, completion 2024-12-31 (estimated), first posted 2023-12-22, last updated 2023-12-22
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Single Segmentectomy group			patients underwent single segment resection,
Lobectomy group			Patients underwent lobectomy
Multiple segmentectomy group			patients underwent multiple segments resection,

+Outcome measures

Primary outcomes

disease free survival [1 YEAR]: Time between surgery and recurrence appearance

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Marco Chiappetta	Roma	Italy

+Publications

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
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
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
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
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
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

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