The Value of Surgical Mediastinal Staging in Clinical N1 Lung Cancer

NCT02222194 | Completed

• 1 other identifier: ASTER 3
• Study Type: observational
• Target: 105
• Locations: 6 countries
• Sites: 10

Brief Summary

In case of PET or CT based cN1 (suspected) NSCLC, ESTS guidelines propose mediastinal staging by echo-endoscopy OR mediastinoscopy. Recent data show a sensitivity of less than 50% for echo-endoscopy to detect N2 disease in cN1 NSCLC patients, while prevalence of mediastinal nodal disease was 24% (unpublished data Aster II).2 The investigators plan to perform a prospective multicentric observational study to measure the sensitivity of mediastinal staging by video-assisted mediastinoscopy (VAM) in cN1 operable and resectable (suspected) NSCLC patients.

Conditions

Non Small Cell Lung Cancer

Keywords

Lung cancer; Surgery; Videomediastinoscopy

Outcome Measures

Primary Outcomes (1)

• Sensitivity of VAM

  Sensitivity (%) of surgical mediastinal staging by video-assisted mediastinoscopy in clinical N1; true positives (TP) = cN1 and pN1 - false negatives (FP) = cN1 and pN2/3; sensitivity is calculated as TP / (TP+FN)

  at surgery (VAM)

Secondary Outcomes (1)

• Prevalence of N2/3 disease after VAM

  at surgery (VAM)

Study Arms (1)

VAM

Patients with operable and resectable cT1-2-selected T3 cN1cM0 NSCLC undergo VAM for mediastinal lymph node staging. After VAM, patients without tissue proof of N2/3 disease at surgical staging undergo a VATS or thoracotomy with systematic lymph node dissection during the same anaesthesia or at a later stage. Sensitivity, NPV and accuracy of staging with VAM will be calculated. Provided N2 lymph node metastases are proven by VAM the patient goes off study protocol and can further be assessed/treated according to local clinical practice.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with operable and resectable cT1-2- selectedT3 cN1 (suspected) NSCLC. (selected T3 = intraparenchymal tumour \>7cm or T3 chest wall or T3 additional nodule, excluding mediastinal invasion or invasion of the main bronchus \< 2cm from the carina)

You may qualify if:

• (Suspected) NSCLC Medical operable and surgical resectable cT1, cT2 selected cT3 (i.e. intraparenchymal tumour \>7cm, T3 chest wall, or T3 based on additional nodule in the lobe of the primary tumour) cN1 based on CT or PET 18 years or older Informed Consent

You may not qualify if:

• History of mediastinoscopy No integrated FDG PET/CT available No videomediastinoscopy available EBUS/EUS for mediastinal staging of present N1 disease cN2: mediastinal nodes enlarged on CT or Pet positive invasion of mediastinal pleura invasion of phrenic nerve invasion of parietal pericardium tumour in main bronchus less than 2cm form the main carina cT4 cM1 former therapy for lung cancer (chemotherapy, radiotherapy, surgery) technical contraindication for videomediastinoscopy ( eg extreme kyphosis, cutaneous tracheostomy, extreme goiter) pregnancy inability to consent

Sponsors & Collaborators

• Johnny Moons: lead

Study Sites (10)

University Hospital Leuven

Leuven, 3000, Belgium

Location

Aix-Marseille University & Hospitals System of Marseille (AP-HM)

Marseille, 13915, France

Location

ELK Berlin Chest Hospital

Berlin, 13125, Germany

Location

Albert-Ludwigs-University Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Katholisches Klinikum Koblenz

Koblenz, 56073, Germany

Location

Katholisches Klinikum, Thoraxchirurgie

Koblenz, 56073, Germany

Location

Hospital Universitari Mutua Terrassa

Barcelona, 08017, Spain

Location

Hospital Clinic; Barcelona University

Barcelona, 08036, Spain

Location

University Hospital, Division of Thoracic Surgery

Zurich, 8091, Switzerland

Location

Istanbul University, Cerrahpasa Medical Faculty

Istanbul, 81080, Turkey (Türkiye)

Location

Related Publications (1)

• Decaluwe H, Dooms C, D'Journo XB, Call S, Sanchez D, Haager B, Beelen R, Kara V, Klikovits T, Aigner C, Tournoy K, Zahin M, Moons J, Brioude G, Trujillo JC, Klepetko W, Turna A, Passlick B, Molins L, Rami-Porta R, Thomas P, Leyn P. Mediastinal staging by videomediastinoscopy in clinical N1 non-small cell lung cancer: a prospective multicentre study. Eur Respir J. 2017 Dec 21;50(6):1701493. doi: 10.1183/13993003.01493-2017. Print 2017 Dec.

  PMID: 29269579 DERIVED

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

• Herbert Decaluwé, MD

  Universitaire Ziekenhuizen KU Leuven

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Data Manager / Clinical Trial Coordinator

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 21, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: May 30, 2017
• Last Updated: July 25, 2017

Record last verified: 2017-07

Locations

DE (4); TU (1); FR (1); ES (2); BE (1); CH (1)