Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node)
DeCOG-SLT
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
1 other identifier
interventional
483
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2005
Longer than P75 for not_applicable
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 2, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 21, 2022
May 1, 2017
12 years
April 2, 2015
December 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Distant metastases free survival
3 Years
Secondary Outcomes (1)
Distant metastases free survival
5 Years
Study Arms (2)
Completion Lymphadenectomy
EXPERIMENTALCompletion Lymphadenectomy and monitoring afterwards
Clinical Monitoring (Palpation and node ultrasound)
EXPERIMENTALMonitoring only
Interventions
Eligibility Criteria
You may qualify if:
- Cutaneous melanoma with a tumour thickness of at least 1,00mm
- Positive sentinel node with micro metastases of max. 2mm in diameter
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Humboldt-Universität Berlin Charité
Berlin, 10117, Germany
Krankenhaus Neukölln
Berlin, 12351, Germany
Universtitäts-Hautklinik Bochum
Bochum, 44791, Germany
Zentralkrankenhaus
Bremen, 28205, Germany
Universität Köln
Cologne, 50924, Germany
Carl-Thiem Klinikum
Cottbus, 03048, Germany
Städtische Kliniken Darmstadt
Darmstadt, 64297, Germany
Städtische Kliniken Dessau
Dessau, 06847, Germany
Städtisches Klinikum Friedrichsstadt
Dresden, 01067, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Heinrich Heine Universität
Düsseldorf, 40225, Germany
Klinikum Erfurt GmbH
Erfurt, 99089, Germany
Universitätsklinikum Erlangen
Erlangen, 91052, Germany
Universitätsklinikum Essen
Essen, 45122, Germany
Klinkum der J. W. Goethe Universität
Frankfurt am Main, 60590, Germany
Klinikum der Albert-Ludwigs-Universität
Freiburg im Breisgau, 79104, Germany
Justus-Liebig-Universität
Giessen, 35385, Germany
Georg-August Universität
Göttingen, 37075, Germany
Allgemeines Krankenhaus St. Georg
Hamburg, 20099, Germany
Klinikum de Ruprecht-Karls-Universität
Heidelberg, 69115, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, 66421, Germany
Klinikum der Friedrich Schiller Universität
Jena, 07740, Germany
Städtische Hautklinik Karlsruhe
Karlsruhe, 76133, Germany
Städtische Kliniken Kassel
Kassel, 34125, Germany
Universität Leipzig
Leipzig, 04103, Germany
Klinkum Lippe-Lemgo GmbH
Lemgo, 32657, Germany
Universitätsklinikum Lübeck
Lübeck, 23538, Germany
Otto-von-Guericke-Universität
Magdeburg, 39120, Germany
Klinik der Philipps-Universität
Marburg, 35033, Germany
Johannes Wesling Klinikum Minden
Minden, 32429, Germany
Ludwig-Maximilians-Universität
Munich, 80337, Germany
Technische Universität
Munich, 80802, Germany
Städt. Krankenhaus München-Schwabing
Munich, 80804, Germany
Universitätsklinkum Münster
Münster, 48149, Germany
Städtische Kliniken Oldenburg
Oldenburg, 26133, Germany
Klinkum der Universität
Regensburg, 93053, Germany
Eberhard-Karls Universität
Tübingen, 72076, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Katholisches Krankenhaus
Unna, 59423, Germany
Klinkum Wuppertal GmbH
Wuppertal, 42117, Germany
Universitätsklinik und Poliklinik
Würzburg, 97080, Germany
Related Publications (2)
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.
PMID: 31557067DERIVEDLeiter 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.
PMID: 27161539DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Claus Garbe, MD
University Hopsital Tübingen
- STUDY CHAIR
Rudolf Stadler, MD
Johannes Wesling Klinikum Minden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2015
First Posted
May 5, 2015
Study Start
December 1, 2005
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
December 21, 2022
Record last verified: 2017-05