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

NCT02730897 | Completed

• 1 other identifier: NUTS
• Study Type: observational
• Target: 956
• Locations: 0 countries
• Sites: N/A

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

Conditions

Non Small Cell Lung Cancer

Keywords

Surgery; Thoracotomy; VATS

Outcome Measures

Primary Outcomes (1)

• Incidence of nodal (N1 and N2) upstaging

  Incidence of nodal (N1 and N2) upstaging stratified by 'central' versus 'peripheral' tumor location

  immediate postoperative

Secondary Outcomes (1)

• Overall Survival

  1 yr postoperative

Study Arms (2)

VATS

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

Procedure: Central/Peripheral

Open

Patients operated by means of open thoracotomy

Procedure: Central/Peripheral

Interventions

Central/Peripheral PROCEDURE

Central versus peripheral location of the primary tumor

Open; VATS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Per centre, a list of consecutive patients operated for cStage-I NSCLC in 2014 is selected. cStage-I is decided based on all information before resection is started in accordance to the 7th edition of TNM

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gasthuisberg: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Multicenter Studies as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Herbert Decaluwé, MD

  Universitaire Ziekenhuizen KU Leuven

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trial Coordinator

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 7, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: January 1, 2017
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share