Multicentric Analysis of Predictors of N1 Upstaging After Resection of cStage-I NSCLC

NCT ID: NCT02730897

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 956 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-01-31

Brief Summary

Five papers showed a lower N1 nodal upstaging with video-assisted thoracic surgery (VATS) compared to open surgery in patients with cStage-I NSCLC . This finding questions the oncologic quality of minimal invasive lung cancer surgery, especially the quality of hilar and intrapulmonary lymh node dissection. However, these retrospective studies did not include analysis of central tumor location, although central tumors have a reported higher chance of N1 upstaging . Possibly, this creates a selection bias as surgeons might select central lesions deliberately for open surgery in line with initial VATS feasibility reports

Detailed Description

After optimal preoperative staging, 10 to 25% of patients with clinical stage I (cStage-I) non-small cell lung cancer (NSCLC) are found to have unforeseen positive lymph nodes during resection.

Central tumors, even if they are smaller than 3cm (cT1), have a higher incidence of both intrapulmonary or hilar (N1) or ipsilateral mediastinal (N2) lymph node involvement in comparison to peripheral lesions.

In a cohort of patients that underwent identical preoperative mediastinal evaluation and postoperative pathologic tissue examination of equal quality, nodal upstaging can be used as a quality indicator of oncologic thoracic surgery. Or, it can be used as an instrument to compare different techniques, such as thoracoscopic (VATS) versus open lung resections for lung cancer.

Five papers showed a lower N1 nodal upstaging with video-assisted thoracic surgery (VATS) compared to open surgery. These retrospective studies did not include tumor location.

The investigators hypothesize that this creates a bias as surgeons might have chosen an open approach when the tumor was centrally located. This is in line with initial feasibility reports and guidelines that excluded patients with central lesions. This results in a higher prevalence of positive N1 nodes in patients operated with the open approach.

Our single centre analysis showed a one in three chance of nodal upstaging in central located cStage-I tumors , multivariate analysis showed central location to be the only significant predictor for upstaging, and not the surgical technique.

The aim of this multicentric study is to investigate risk factors for nodal upstaging, including tumor location, in patients with cStage-I NSCLC and validate previous findings.

Conditions

Non Small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

VATS

Patients operated by means of minimal invasive technique (VATS or roboticVATS)

Central/Peripheral

Intervention Type: PROCEDURE

Central versus peripheral location of the primary tumor

Open

Patients operated by means of open thoracotomy

Central/Peripheral

Intervention Type: PROCEDURE

Central versus peripheral location of the primary tumor

Interventions

Central/Peripheral

Central versus peripheral location of the primary tumor

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients operated in 2014
• NSCLC on final pathology
• cStage-I (cT1-2a cN0 cM0 ) before start of incision for anatomical resection.
• This includes: open/VATS/ Robotic Assisted Thoracoscopic Surgery (RATS)
• This includes: lobectomy, bilobectomy, sleeve or pneumonectomy (not wedge)

Exclusion Criteria

• Higher clinical stage than cStage-I
• Former therapy for lung cancer (chemotherapy, radiotherapy, surgery)
• Metastatic disease
• Induction chemo- or radiotherapy
• Non-anatomical resections (wedge)
• Previous lymph node disease
• No positron emission tomography (PET) or Missing PET report

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Gasthuisberg

OTHER

Sponsor Role: lead

Responsible Party

Johnny Moons

Clinical Trial Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Herbert Decaluwé, MD

Role: STUDY_DIRECTOR

Universitaire Ziekenhuizen KU Leuven

Other Identifiers

NUTS

Identifier Type: -

Identifier Source: org_study_id