Clinical trial NCT06180239: Segmentectomy vs Lobectomy
Official title: Different Segmentectomy vs Lobectomy Comparison in NSCLC
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-small Cell Lung Cancer Stage I
Surgery
Keywords: segmentectomy
lobectomy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Regina Elena Cancer Institute
name: Istituto Europeo di Oncologia
name: University of Pisa
name: A.O.U. Città della Salute e della Scienza - Molinette Hospital
name: Azienda Ospedaliera "Sant'Andrea"
First posted: 2023-12-22
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: disease free survival
timeFrame: 1 YEAR
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Marco Chiappetta
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.