MEDIASTinal staging of non-small cell lung cancer by endobronchial and endoscopic ultrasonography with or without additional surgical mediastinoscopy (MEDIASTrial): a statistical analysis plan
| Autor: | Bousema, Jelle E., Annema, Jouke T., van der Heijden, Erik H. F. M., Verhagen, Ad F. T. M., Dijkgraaf, Marcel G. W., van den Broek, Frank J. C., Papen-Botterhuis, Nicole E., Youssef-el Soud, Maggy, van Boven, Wim J., Daniels, Johannes M. A., Heineman, David J., Zandbergen, Harmen R., Brocken, Pepijn, Horn, Thirza, Steup, Willem H., Braun, Jerry, Ramai, Rajen S. R. S., Beck, Naomi, Barlo, Nicole P., van Dorp, Martijn, Schreurs, W. Hermien, Dingemans, Anne-Marie C., Maessen, Jos G., Claessens, Niels J. M., Lardenoije, Jan-Willem H. P., Hiddinga, Birgitta I., van de Wauwer, Caroline, van der Wekken, Anthonie J., Hanselaar, Wessel E., Kortekaas, Robert Th J., Rijna, Herman, Bootsma, Gerben P., Vissers, Yvonne L. J., Veen, Eelco J., van der Leest, Cor H., Citgez, Emanuel, van Duyn, Eino B., Marres, Geertruid M. H., van Thiel, Eric R., van Schil, Paul E., van Meerbeeck, Jan P., Smakman, Niels, van der Meer, Femke, Saboerali, Mohammed D., Bosch, Anne Marie, de Jong, Wouter K., van Rossem, Charles C., Lie, W. Johan, Kouwenhoven, Ewout A., Staal- van den Brekel, A. Jeske |
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| Přispěvatelé: | Pulmonary medicine, Surgery, Cardio-thoracic surgery, CCA - Imaging and biomarkers, ACS - Heart failure & arrhythmias, Graduate School, APH - Methodology, Pulmonology, Epidemiology and Data Science, Cardiothoracic Surgery |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Statistical analysis plan Lung Neoplasms Medicine (miscellaneous) 030204 cardiovascular system & hematology Update Mediastinoscopy Endosonography Non-small cell lung carcinoma 03 medical and health sciences All institutes and research themes of the Radboud University Medical Center 0302 clinical medicine Statistical Analysis Plan Carcinoma Non-Small-Cell Lung medicine Humans Pharmacology (medical) 030212 general & internal medicine Lung cancer Neoplasm Staging Netherlands lcsh:R5-920 Intention-to-treat analysis medicine.diagnostic_test business.industry Other Research Radboud Institute for Health Sciences [Radboudumc 0] medicine.disease Confidence interval Dissection Thoracic surgery Mediastinal nodal staging Cardiothoracic surgery Mediastinal lymph node Quality of Life Radiology Lymph Nodes lcsh:Medicine (General) business Rare cancers Radboud Institute for Health Sciences [Radboudumc 9] |
| Zdroj: | on behalf of the MEDIASTrial study group 2021, ' MEDIASTinal staging of non-small cell lung cancer by endobronchial and endoscopic ultrasonography with or without additional surgical mediastinoscopy (MEDIASTrial): a statistical analysis plan ', Trials, vol. 22, no. 1, 168 . https://doi.org/10.1186/s13063-021-05127-6 Trials, 22(1):168. BioMed Central Trials Trials, 22 Trials, 22, 1 Trials, Vol 22, Iss 1, Pp 1-13 (2021) |
| ISSN: | 1745-6215 |
| DOI: | 10.1186/s13063-021-05127-6 |
| Popis: | Background Invasive mediastinal nodal staging is recommended by guidelines in selected patients with resectable non-small cell lung cancer (NSCLC). Endosonography is recommended as initial staging technique, followed by confirmatory mediastinoscopy in case of negative N2 or N3 cytology after endosonography. Confirmatory mediastinoscopy however is under debate owing its limited additional diagnostic value, its associated morbidity and its delay in the start of lung cancer treatment. The MEDIASTrial examines whether confirmatory mediastinoscopy can be safely omitted after negative endosonography in mediastinal nodal staging of NSCLC. The present work is the proposed statistical analysis plan of the clinical consequences of omitting mediastinoscopy, which is submitted before closure of the MEDIASTrial and before knowledge of any results was done to enhance transparency of scientific behaviour. Methods The primary outcome measure of this non-inferiority trial will be unforeseen N2 disease resulting from lobe-specific mediastinal lymph node dissection. For non-inferiority, the upper limit of the 95% confidence interval of the unforeseen N2 rate in the group without mediastinoscopy should not exceed 14.3% in order to probably have no negative impact on survival. Since this is a non-inferiority trial, both an intention to treat (ITT) and a per protocol (PP) analyses will be done. The ITT and the PP analyses should both indicate non-inferiority before the diagnostic strategy omitting mediastinoscopy will be interpreted as non-inferior to the strategy with mediastinoscopy. Secondary outcome measures include 30-day major morbidity and mortality, the total number of days of hospital care, overall and disease free 2-year survival, generic and disease-specific health related quality of life and cost-effectiveness and cost-utility of staging strategies with and without mediastinoscopy. Discussion The MEDIASTrial will determine if confirmatory mediastinoscopy can be omitted after tumour negative systematic endosonography in invasive mediastinal staging of patients with resectable NSCLC. Trial registration Netherlands Trial Register NL6344/NTR6528. Registered on 2017 July 06 |
| Databáze: | OpenAIRE |
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