Single Scope Staging of Lung Cancer With Endosonography

Non Small Cell Lung Cancer (NSCLC) Clinical Trial

— SCORE  

Official title:

Complete Endosonographic Staging of Lung Cancer: a Systematic Single Scope Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014324
• Other study ID #: NL42787.018.13
• Status: Completed
• Phase: N/A
• First received: May 30, 2013
• Last updated: October 17, 2014
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Rationale: Lung cancer is the most commonly diagnosed cancer worldwide and is the most frequent cause of cancer death. Accurate staging is important because it directs treatment and prognosis. Mediastinal staging can be done by both EBUS-TBNA and EUS-FNA. These two techniques have a complementary diagnostic range and the combined procedure is suited for assessment of almost the entire mediastinum. In practice, when mediastinal tissue staging is indicated, endoscopists often perform either an EBUS or an EUS investigation (instead of the combined procedure). Second, frequently only one or two, by imaging suspected lymph node stations, are sampled (ie. targeted approach).

Objectives: main and secondary:

1. Complete endosonographic (combined endobronchial and esophageal) staging using a single EBUS scope improves locoregional staging (N2, N3, T4) versus EBUS staging alone.

2. Systematic mediastinal staging results in improved locoregional staging compared to PET-CT directed assessment of the mediastinum (ie targeted approach).

Study population: Patients with potentially operable and resectable NSCLC are eligible if there is an indication for mediastinal nodal sampling. Patients have an indication for EBUS-TBNA.

Intervention: Patients will undergo an EBUS investigation followed by EUS-B in the same session. During this single scope procedure, lymph nodes that are suspected on prior CT-PET imaging and on subsequent ultrasound are sampled.

Main study endpoint: The main study parameter is the sensitivity for locoregional disease (N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in comparison with EBUS staging alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• (Suspected) NSCLC;

• Indication for mediastinal nodal assessment;

• Suspected mediastinal lymph nodes within reach of EBUS;

• Age 18 years or older;

• Clinically fit to undergo surgical resection of the lung tumor;

• Provision of a written informed consent;

Exclusion Criteria:

• Mediastinal re-staging after neo-adjuvant treatment;

• Indication for EUS other than mediastinal staging, eg a for malignancy

• suspected left adrenal;

• Active malignancy with a life expectancy of less than two years;

• Former therapy for lung cancer (chemotherapy, radiotherapy or surgery);

• Technical contraindication for EBUS or EUS (eg, esophagus stenosis);

• Pregnancy;

• Inability to consent;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Complete Endosonography
• Indication Mediastinal Staging
• Lung Neoplasms
• Non Small Cell Lung Cancer (NSCLC)

Intervention

Procedure:
• Endosonography
Complete endosonographic mediastinal staging is performed in 2 steps: Systematic EBUS (airways) Systematic EUS-B (esophagus)

Locations

Country	Name	City	State
Belgium	Onze-Lieve-Vrouwen-Ziekenhuis	Aalst
Belgium	Universitair Ziekenhuis Leuven	Leuven
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland
Netherlands	Antoni van Leeuwenhoek ziekenhuis	Amsterdam
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam
Netherlands	Leids Universitair Medisch Centrum	Leiden
Netherlands	Universitair Medisch Centrum st Radboud	Nijmegen
Netherlands	Isala klinieken	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity for locoregional disease (N2, N3, T4 disease).	Sensitivity is defined as number of true positives (pathologic proof of a nodal metastases) divided by the number of true positives and false negatives (thoracotomy with nodal dissection is the reference standard to detect false negatives).; The main study parameter is the sensitivity for locoregional disease (N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in comparison with EBUS staging alone.; In the event of pathological proof of mediastinal metastases (N2/N3) by endosonography patients are classified as having locally advanced disease (stage III) and the study stops. When no mediastinal metastases are found by endosonography, surgical verification will take place (reference standard).	from inclusion untill either pathological proof of mediastinal metastases by endospnography or 1 week after surgical verification	No
Secondary	Sensitivity for locally advanced disease (N2-3 metastases, T4). Systematic assessment and sampling of mediastinal lymph nodes versus PET-CT directed assessment of the mediastinum.	Sensitivity for locally advanced disease (N2-3 metastases, T4) of systematic assessment and sampling of mediastinal lymph nodes in comparison to PET-CT directed assessment of the mediastinum (ie targeted approach).	from inclusion untill either pathological proof of mediastinal metastases by endosonography or 1 week after surgical verification	No