Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node)
NCT ID: NCT02434107
Last Updated: 2022-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
483 participants
INTERVENTIONAL
2005-12-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study was planned to analyse the survival outcome of patients with a positive SN receiving complete lymphadenectomy versus watchful waiting.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Completion Lymphadenectomy
Completion Lymphadenectomy and monitoring afterwards
Completion Lymphadenectomy
Clinical Monitoring (Palpation and node ultrasound)
Monitoring only
Clinical Monitoring (Palpation and node ultrasound)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Completion Lymphadenectomy
Clinical Monitoring (Palpation and node ultrasound)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Positive sentinel node with micro metastases of max. 2mm in diameter
Exclusion Criteria
* Cutaneous melanoma located in the head/neck region
* Evidence of satellite, in transit or local metastases / recurrences
* Macro metastases of the SN or micro metastases of \>2mm in diameter
* Additional immune-suppressive therapy
* Pregnant of lactating women
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital Tuebingen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Claus Garbe, MD
Role: STUDY_DIRECTOR
University Hopsital Tübingen
Rudolf Stadler, MD
Role: STUDY_CHAIR
Johannes Wesling Klinikum Minden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Humboldt-Universität Berlin Charité
Berlin, , Germany
Krankenhaus Neukölln
Berlin, , Germany
Universtitäts-Hautklinik Bochum
Bochum, , Germany
Zentralkrankenhaus
Bremen, , Germany
Universität Köln
Cologne, , Germany
Carl-Thiem Klinikum
Cottbus, , Germany
Städtische Kliniken Darmstadt
Darmstadt, , Germany
Städtische Kliniken Dessau
Dessau, , Germany
Städtisches Klinikum Friedrichsstadt
Dresden, , Germany
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Heinrich Heine Universität
Düsseldorf, , Germany
Klinikum Erfurt GmbH
Erfurt, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Essen
Essen, , Germany
Klinkum der J. W. Goethe Universität
Frankfurt am Main, , Germany
Klinikum der Albert-Ludwigs-Universität
Freiburg im Breisgau, , Germany
Justus-Liebig-Universität
Giessen, , Germany
Georg-August Universität
Göttingen, , Germany
Allgemeines Krankenhaus St. Georg
Hamburg, , Germany
Klinikum de Ruprecht-Karls-Universität
Heidelberg, , Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, , Germany
Klinikum der Friedrich Schiller Universität
Jena, , Germany
Städtische Hautklinik Karlsruhe
Karlsruhe, , Germany
Städtische Kliniken Kassel
Kassel, , Germany
Universität Leipzig
Leipzig, , Germany
Klinkum Lippe-Lemgo GmbH
Lemgo, , Germany
Universitätsklinikum Lübeck
Lübeck, , Germany
Otto-von-Guericke-Universität
Magdeburg, , Germany
Klinik der Philipps-Universität
Marburg, , Germany
Johannes Wesling Klinikum Minden
Minden, , Germany
Ludwig-Maximilians-Universität
Munich, , Germany
Technische Universität
Munich, , Germany
Städt. Krankenhaus München-Schwabing
Munich, , Germany
Universitätsklinkum Münster
Münster, , Germany
Städtische Kliniken Oldenburg
Oldenburg, , Germany
Klinkum der Universität
Regensburg, , Germany
Eberhard-Karls Universität
Tübingen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Katholisches Krankenhaus
Unna, , Germany
Klinkum Wuppertal GmbH
Wuppertal, , Germany
Universitätsklinik und Poliklinik
Würzburg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Leiter U, Stadler R, Mauch C, Hohenberger W, Brockmeyer NH, Berking C, Sunderkotter C, Kaatz M, Schatton K, Lehmann P, Vogt T, Ulrich J, Herbst R, Gehring W, Simon JC, Keim U, Verver D, Martus P, Garbe C; German Dermatologic Cooperative Oncology Group. Final Analysis of DeCOG-SLT Trial: No Survival Benefit for Complete Lymph Node Dissection in Patients With Melanoma With Positive Sentinel Node. J Clin Oncol. 2019 Nov 10;37(32):3000-3008. doi: 10.1200/JCO.18.02306. Epub 2019 Sep 26.
Leiter U, Stadler R, Mauch C, Hohenberger W, Brockmeyer N, Berking C, Sunderkotter C, Kaatz M, Schulte KW, Lehmann P, Vogt T, Ulrich J, Herbst R, Gehring W, Simon JC, Keim U, Martus P, Garbe C; German Dermatologic Cooperative Oncology Group (DeCOG). Complete lymph node dissection versus no dissection in patients with sentinel lymph node biopsy positive melanoma (DeCOG-SLT): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):757-767. doi: 10.1016/S1470-2045(16)00141-8. Epub 2016 May 5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
V1410112004
Identifier Type: -
Identifier Source: org_study_id