Non Small Cell Lung Cancer Clinical Trial
— ASTER3Official title:
Assessment of Surgical Mediastinal sTaging in cN1 Lung canceR
Verified date | July 2017 |
Source | University Hospital, Gasthuisberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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for echo-endoscopy to detect N2 disease in cN1 NSCLC patients, while prevalence of mediastinal nodal disease was 24% (unpublished data Aster II).2 The investigators plan to perform a prospective multicentric observational study to measure the sensitivity of mediastinal staging by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.
Status | Completed |
Enrollment | 105 |
Est. completion date | May 30, 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Leuven | Leuven | |
France | Aix-Marseille University & Hospitals System of Marseille (AP-HM) | Marseille | |
Germany | ELK Berlin Chest Hospital | Berlin | |
Germany | Albert-Ludwigs-University Freiburg | Freiburg | |
Germany | Katholisches Klinikum Koblenz | Koblenz | |
Germany | Katholisches Klinikum, Thoraxchirurgie | Koblenz | |
Spain | Hospital Clinic; Barcelona University | Barcelona | |
Spain | Hospital Universitari Mutua Terrassa | Barcelona | |
Switzerland | University Hospital, Division of Thoracic Surgery | Zurich | |
Turkey | Istanbul University, Cerrahpasa Medical Faculty | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Johnny Moons |
Belgium, France, Germany, Spain, Switzerland, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Prevalence of N2/3 disease after VAM | % of patients with cN1 disease who show pN2/3 disease after VAM | at surgery (VAM) |
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