Melanoma Clinical Trial
— DeCOG-SLTOfficial title:
Controlled and Prospective Randomised Study to Compare Complete Lymph Node Dissection Versus Watchful Waiting in Patients With Malignant Melanoma With a Tumour Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node
| NCT number | NCT02434107 |
| Other study ID # | V1410112004 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2005 |
| Est. completion date | December 2017 |
| Verified date | May 2017 |
| Source | University Hospital Tuebingen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 483 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Cutaneous melanoma with a tumour thickness of at least 1,00mm - Positive sentinel node with micro metastases of max. 2mm in diameter Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Humboldt-Universität Berlin Charité | Berlin | |
| Germany | Krankenhaus Neukölln | Berlin | |
| Germany | Universtitäts-Hautklinik Bochum | Bochum | |
| Germany | Zentralkrankenhaus | Bremen | |
| 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/Main | |
| Germany | Klinikum der Albert-Ludwigs-Universität | Freiburg | |
| 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 Köln | Köln | |
| 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 | Städt. Krankenhaus München-Schwabing | Munich | |
| Germany | Technische Universität | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Tuebingen |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Distant metastases free survival | 3 Years | ||
| Secondary | Distant metastases free survival | 5 Years |
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