Single Scope Staging of Lung Cancer With Endosonography (SCORE)

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

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.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer (NSCLC); Indication Mediastinal Staging; Complete Endosonography
• Intervention / Treatment: Procedure: Endosonography

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • Onze-Lieve-Vrouwen-Ziekenhuis
  • Leuven, Belgium
    • Universitair Ziekenhuis Leuven
• Netherlands
  • Alkmaar, Netherlands
    • Medisch Centrum Alkmaar
  • Amsterdam, Netherlands
    • Antoni van Leeuwenhoek Ziekenhuis
  • Amsterdam, Netherlands
    • Vrije Universiteit Medisch Centrum
  • Leiden, Netherlands
    • Leids Universitair Medisch Centrum
  • Nijmegen, Netherlands
    • Universitair Medisch Centrum st Radboud
  • Zwolle, Netherlands
    • Isala Klinieken
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105AZ
      • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
(suspected) NSCLC, mediastinal staging, endosonography; Patients with potentially medically operable and resectable NSCLC are eligible if there is an indication for pathological evaluation of mediastinal lymph nodes.	Procedure: Endosonography; Complete endosonographic mediastinal staging is performed in 2 steps: Systematic EBUS (airways); Systematic EUS-B (esophagus); Other Names: EBUS; EUS-B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Jouke T Annema, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: May 30, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (Estimate): December 18, 2013

Study Record Updates

• Last Update Posted (Estimate): October 20, 2014
• Last Update Submitted That Met QC Criteria: October 17, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: NL42787.018.13