- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02222194
The Value of Surgical Mediastinal Staging in Clinical N1 Lung Cancer (ASTER3)
Assessment of Surgical Mediastinal sTaging in cN1 Lung canceR
Study Overview
Status
Conditions
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for mediastinal staging of 38% (ITT analysis), while the prevalence of mediastinal nodal disease was 24% (unpublished data Aster 2) 2.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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Leuven, Belgium, 3000
- University Hospital Leuven
-
-
-
-
-
Marseille, France, 13915
- Aix-Marseille University & Hospitals System of Marseille (AP-HM)
-
-
-
-
-
Berlin, Germany, 13125
- ELK Berlin Chest Hospital
-
Freiburg, Germany, 79106
- Albert-Ludwigs-University Freiburg
-
Koblenz, Germany, 56073
- Katholisches Klinikum Koblenz
-
Koblenz, Germany, 56073
- Katholisches Klinikum, Thoraxchirurgie
-
-
-
-
-
Barcelona, Spain, 08017
- Hospital Universitari Mútua Terrassa
-
Barcelona, Spain, 08036
- Hospital Clinic; Barcelona University
-
-
-
-
-
Zurich, Switzerland, 8091
- University Hospital, Division of Thoracic Surgery
-
-
-
-
-
Istanbul, Turkey, 81080
- Istanbul University, Cerrahpasa Medical Faculty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
at surgery (VAM)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of N2/3 disease after VAM
Time Frame: at surgery (VAM)
|
% of patients with cN1 disease who show pN2/3 disease after VAM
|
at surgery (VAM)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Herbert Decaluwé, MD, Universitaire Ziekenhuizen KU Leuven
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASTER 3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non Small Cell Lung Cancer
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
Memorial Sloan Kettering Cancer CenterAstraZenecaRecruitingNSCLC | Lung Cancer | Non-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | PD-L1 Gene Mutation | Non-small Cell Lung Cancer Stage IIIA | Non-small Cell Lung Cancer Stage IIUnited States
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)WithdrawnStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States