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The Value of Surgical Mediastinal Staging in Clinical N1 Lung Cancer (ASTER3)

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ClinicalTrials.gov Identifier: NCT02222194
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Johnny Moons, University Hospital, Gasthuisberg

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for echo-endoscopy to detect N2 disease in cN1 NSCLC patients, while prevalence of mediastinal nodal disease was 24% (unpublished data Aster II).2 The investigators plan to perform a prospective multicentric observational study to measure the sensitivity of mediastinal staging by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.

Condition or disease
Non Small Cell Lung Cancer

Detailed Description:

Few reports in the literature evaluated the final pathological stage distribution of patients with resectable and operable non-small cell lung cancer (NSCLC) with clinical stage cN1. These retrospective series demonstrated that patients with computed tomography (CT) based cN1 often had clinically occult mediastinal lymph node metastases (N2/3 disease). Hishida et al. reported that 30% of 143 patients with cN1 were diagnosed N2/3 by mediastinoscopy3. Watanabe et al. reported that 37% of 168 patients with cN1 were diagnosed N2/3 by mediastinoscopy 4. Adding FDG-positron emission tomography (PET) to CT might enable the detection of N2/3 disease among these cN1 patients, but negative PET findings do not necessarily exclude N2/3 disease. Kim et al reported that 19,2 % of 99 patients with cN1, in whom cN2 was ruled out by PET-CT scan, were found to have pathologic N2 disease at pulmonary resection with mediastinal lymph node dissection.5 In conclusion, 20-30% of patients with cN1 nodes on imaging, and normal sized FDG-negative mediastinal lymph nodes on CT and PET have malignant involvement in their mediastinal nodes.

The ACCP guidelines state that invasive preoperative mediastinal staging should be performed in these cN1 patients 6. The updated ESTS guidelines recommend mediastinal staging by echo-endoscopic or mediastinoscopy.1 Non-randomized trials suggested the potential of linear endosonography for mediastinal staging 7-9. However, the patients with cN1 disease form only a minority in these studies. A recently performed prospective ASTER 2 trial (N=100) showed a sensitivity of echo-endoscopic for mediastinal staging of 38% (ITT analysis), while the prevalence of mediastinal nodal disease was 24% (unpublished data Aster 2) 2. The conclusion made by ASTER 2 is that a negative endosonography must be followed by a VAM. However, the investigators consider such double approach not cost-effective in a setting with N2 prevalence <30%. Therefore, it seems reasonable to perform a VAM instead of an endosonography in cN1 patients, which is one of the proposed strategies in the recent ESTS guidelines.1 However, there is no prospective study to date that assessed the sensitivity, NPV and accuracy of VAM in a well-defined group of cN1 patients.

Several publications have demonstrated a lobe-specific mediastinal nodal drainage for upper versus lower lobe NSCLC. Shapiro et al conclude that in early lung cancer, including cN1 disease, lobe-specific mediastinal dissection is warranted 10. However, in this study the only patient with a positive subcarinal node, upper lobe tumour, and negative superior mediastinal nodes had positive N1 nodes. To the investigators knowledge there is no study focussing on mediastinal nodal dissemination patterns in cN1 patients.

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Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Surgical Mediastinal sTaging in cN1 Lung canceR
Study Start Date : August 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort
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.




Primary Outcome Measures :
  1. Sensitivity of VAM [ Time Frame: at surgery (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)


Secondary Outcome Measures :
  1. Prevalence of N2/3 disease after VAM [ Time Frame: at surgery (VAM) ]
    % of patients with cN1 disease who show pN2/3 disease after VAM



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

Inclusion Criteria:

(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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222194


Locations
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Belgium
University Hospital Leuven
Leuven, Belgium, 3000
France
Aix-Marseille University & Hospitals System of Marseille (AP-HM)
Marseille, France, 13915
Germany
ELK Berlin Chest Hospital
Berlin, Germany, 13125
Albert-Ludwigs-University Freiburg
Freiburg, Germany, 79106
Katholisches Klinikum Koblenz
Koblenz, Germany, 56073
Katholisches Klinikum, Thoraxchirurgie
Koblenz, Germany, 56073
Spain
Hospital Universitari Mutua Terrassa
Barcelona, Spain, 08017
Hospital Clinic; Barcelona University
Barcelona, Spain, 08036
Switzerland
University Hospital, Division of Thoracic Surgery
Zurich, Switzerland, 8091
Turkey
Istanbul University, Cerrahpasa Medical Faculty
Istanbul, Turkey, 81080
Sponsors and Collaborators
Johnny Moons
Investigators
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Study Director: Herbert Decaluwé, MD Universitaire Ziekenhuizen Leuven
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johnny Moons, Data Manager / Clinical Trial Coordinator, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT02222194    
Other Study ID Numbers: ASTER 3
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Keywords provided by Johnny Moons, University Hospital, Gasthuisberg:
Lung cancer
Surgery
Videomediastinoscopy
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases