Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node)
- Conditions
- Melanoma
- Interventions
- Procedure: Clinical Monitoring (Palpation and node ultrasound)Procedure: Completion Lymphadenectomy
- Registration Number
- NCT02434107
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
Sentinel lymph node biopsy (SLNB) is considered as standard diagnostic procedure in melanoma patients carrying a reasonable risk for metastases. In numerous studies the prognostic role of micro metastases in the sentinel node (SN) was described. However, the prognostic value of a complete lymph node dissection in patients with a positive SN is still unclear.
This study was planned to analyse the survival outcome of patients with a positive SN receiving complete lymphadenectomy versus watchful waiting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 483
- Cutaneous melanoma with a tumour thickness of at least 1,00mm
- Positive sentinel node with micro metastases of max. 2mm in diameter
- Mucosal or ocular melanoma
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clinical Monitoring (Palpation and node ultrasound) Clinical Monitoring (Palpation and node ultrasound) Monitoring only Completion Lymphadenectomy Completion Lymphadenectomy Completion Lymphadenectomy and monitoring afterwards
- Primary Outcome Measures
Name Time Method Distant metastases free survival 3 Years
- Secondary Outcome Measures
Name Time Method Distant metastases free survival 5 Years
Trial Locations
- Locations (41)
Städtische Kliniken Darmstadt
🇩🇪Darmstadt, Germany
Ludwig-Maximilians-Universität
🇩🇪Munich, Germany
Universitätsklinkum Münster
🇩🇪Münster, Germany
Krankenhaus Neukölln
🇩🇪Berlin, Germany
Humboldt-Universität Berlin Charité
🇩🇪Berlin, Germany
Universtitäts-Hautklinik Bochum
🇩🇪Bochum, Germany
Zentralkrankenhaus
🇩🇪Bremen, Germany
Carl-Thiem Klinikum
🇩🇪Cottbus, 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
Klinikum der Albert-Ludwigs-Universität
🇩🇪Freiburg, Germany
Klinkum der J. W. Goethe Universität
🇩🇪Frankfurt/Main, Germany
Allgemeines Krankenhaus St. Georg
🇩🇪Hamburg, Germany
Justus-Liebig-Universität
🇩🇪Giessen, Germany
Georg-August Universität
🇩🇪Göttingen, Germany
Universitätsklinikum des Saarlandes
🇩🇪Homburg/Saar, Germany
Klinikum de Ruprecht-Karls-Universität
🇩🇪Heidelberg, Germany
Klinikum der Friedrich Schiller Universität
🇩🇪Jena, Germany
Städtische Hautklinik Karlsruhe
🇩🇪Karlsruhe, Germany
Klinkum Lippe-Lemgo GmbH
🇩🇪Lemgo, Germany
Städtische Kliniken Kassel
🇩🇪Kassel, Germany
Universität Köln
🇩🇪Köln, Germany
Universität Leipzig
🇩🇪Leipzig, Germany
Universitätsklinikum Lübeck
🇩🇪Lübeck, Germany
Otto-von-Guericke-Universität
🇩🇪Magdeburg, Germany
Klinik der Philipps-Universität
🇩🇪Marburg, Germany
Johannes Wesling Klinikum Minden
🇩🇪Minden, Germany
Städt. Krankenhaus München-Schwabing
🇩🇪Munich, Germany
Technische Universität
🇩🇪Munich, Germany
Städtische Kliniken Oldenburg
🇩🇪Oldenburg, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Eberhard-Karls Universität
🇩🇪Tübingen, Germany
Klinkum der Universität
🇩🇪Regensburg, Germany
Katholisches Krankenhaus
🇩🇪Unna, Germany
Klinkum Wuppertal GmbH
🇩🇪Wuppertal, Germany
Universitätsklinik und Poliklinik
🇩🇪Würzburg, Germany