Preoperative Lymph Node Staging With EBUS-TBNA in Clinical N0 Non Small-cell Lung Cancer

NCT04828850 | Unknown

• 1 other identifier: IEO1030
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The introduction of modern staging systems has increased the detection of small peripheral lung cancers at an early stage \[1\]. Stage I non-small-cell lung cancers (NSCLCs) are confined to the lung without lymph node involvement, and surgical resection is currently considered the standard therapeutic approach. Nodal staging is initially performed non-invasively with computer tomography (CT) and positron emission tomography (PET) scans followed by minimally invasive staging with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) when CT and/or PET are suggestive of mediastinal nodal involvement. Lobectomy with radical lymphadenectomy is currently considered the treatment of choice for early-stage lung cancer. Several studies demonstrated that primary invasive non- small-cell lung carcinomas \> 2.0 cm were twice as likely to have nodal metastases as carcinomas ≤ 2.0 cm, emphasizing that small lung cancers had less lymph node involvement and confirming a better survival. In our pilot study \[18\] published in 2011 in the European Journal of Thoracic Surgery, no nodal involvement was observed in any of the 62 patients with pulmonary nodule size less than 10 mm, in 20 out of 120 patients (17%) with nodule size 11-20 mm, and in 9 out of 37 tumors (24%) 21-30 mm in size (p = 0.0007). These patients could be spared radical lymph node dissection if deemed not essential, thereby reducing operative risks, postoperative morbidity, and surgery time. A preoperative diagnostic determination to establish the size and correct staging of the tumor is mandatory for appropriate selection of candidates, avoiding unnecessary surgery.

Conditions

Non Small Cell Lung Cancer

Keywords

EBUS-TBNA; NSCLC; Interventional bronchoscopy; Lung cancer

Outcome Measures

Primary Outcomes (1)

• Assessment of the sensitivity of EBUS-TBNA in lymph node staging for early stage lung cancer

  A sample size of 12 upstaged patients will achieve 80% power to detect a difference of sensitivity \>38.4% assuming that the sensitivity under the null hypothesis is 49% (results of the meta-analysis by Leong et al, 2018 \[22\]), and that the actual sensitivity is \>88% (95.6% in the study by Guarize et al, 2018 \[25\]) using a two-sided binomial test.

  17 months

Secondary Outcomes (3)

• Assessment of concordance between EBUS-TBNA and surgery

  17 months

• Assessment of lymph node upstaging by EBUS and surgery

  17 months

• Assessment of the complication rates

  17 months

Study Arms (1)

EBUS-TBNA procedure

EXPERIMENTAL

Single arm protocol. Invasive mediastinal staging with EBUS-TBNA in clinical N0 NSCLC patients candidate to surgical resection with systematic lymphadenectomy.

Procedure: Endobronchial ultrasound transbronchial needle aspiration lymph node staging

Interventions

Endobronchial ultrasound transbronchial needle aspiration lymph node staging PROCEDURE

EBUS-TBNA in clinical N0 NSCLC patients

EBUS-TBNA procedure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected or proven non-small cell lung cancer (NSCLC) clinical stage I and II (diameter \> 1 cm and less than 5 cm, no pleura invasion) clinical N0M0 (8th TNM)
• All patients have to be staged by total body CT scan and PET-FDG
• Negative preoperative staging at hilar and mediastinal level at CT and CT/PET (PET negative and lymph node short axis \< 1 cm at CT scan)
• Age between 18 and 75 years old

You may not qualify if:

• NSCLC smaller or equal than 1 cm
• Unfit for bronchoscopy or surgical resection
• Evidence of locally advanced or metastatic disease
• Prior chemotherapy or radiotherapy for this malignancy
• Other malignancy within the past 5 years except for not melanoma skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
• Previous surgical treatment for lung cancer
• Multiple lung tumors

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Milano, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Juliana Guarize, MD, PhD

  Interventional Pulmonologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana Guarize, MD, PhD

CONTACT

+390257489940; juliana.guarize@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Juliana Guarize, MD, PhD, Interventional Pulmonologist

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 2, 2021
• Study Start: April 1, 2021
• Primary Completion: September 29, 2022
• Study Completion: December 20, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)