Clinical trial NCT02434107: Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Keywords: Sentinel Lymph Node Biopsy
Lymph Node Excision
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Distant metastases free survival
timeFrame: 3 Years
Secondary outcomes:
measure: Distant metastases free survival
timeFrame: 5 Years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Humboldt-Universität Berlin Charité
city: Berlin
country: Germany
facility: Krankenhaus Neukölln
city: Bochum
country: Germany
facility: Universtitäts-Hautklinik Bochum
city: Bremen
country: Germany
facility: Zentralkrankenhaus
city: Cottbus
country: Germany
facility: Carl-Thiem Klinikum
city: Darmstadt
country: Germany
facility: Städtische Kliniken Darmstadt
city: Dessau
country: Germany
facility: Städtische Kliniken Dessau
city: Dresden
country: Germany
facility: Städtisches Klinikum Friedrichsstadt
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Düsseldorf
country: Germany
facility: Heinrich Heine Universität
city: Erfurt
country: Germany
facility: Klinikum Erfurt GmbH
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt/Main
country: Germany
facility: Klinkum der J. W. Goethe Universität
city: Freiburg
country: Germany
facility: Klinikum der Albert-Ludwigs-Universität
city: Giessen
country: Germany
facility: Justus-Liebig-Universität
city: Göttingen
country: Germany
facility: Georg-August Universität
city: Hamburg
country: Germany
facility: Allgemeines Krankenhaus St. Georg
city: Heidelberg
country: Germany
facility: Klinikum de Ruprecht-Karls-Universität
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Jena
country: Germany
facility: Klinikum der Friedrich Schiller Universität
city: Karlsruhe
country: Germany
facility: Städtische Hautklinik Karlsruhe
city: Kassel
country: Germany
facility: Städtische Kliniken Kassel
city: Köln
country: Germany
facility: Universität Köln
city: Leipzig
country: Germany
facility: Universität Leipzig
city: Lemgo
country: Germany
facility: Klinkum Lippe-Lemgo GmbH
city: Lübeck
country: Germany
facility: Universitätsklinikum Lübeck
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universität
city: Marburg
country: Germany
facility: Klinik der Philipps-Universität
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Munich
country: Germany
facility: Ludwig-Maximilians-Universität
city: Munich
country: Germany
facility: Technische Universität
city: Munich
country: Germany
facility: Städt. Krankenhaus München-Schwabing
city: Münster
country: Germany
facility: Universitätsklinkum Münster
city: Oldenburg
country: Germany
facility: Städtische Kliniken Oldenburg
city: Regensburg
country: Germany
facility: Klinkum der Universität
city: Tübingen
country: Germany
facility: Eberhard-Karls Universität
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Unna
country: Germany
facility: Katholisches Krankenhaus
city: Wuppertal
country: Germany
facility: Klinkum Wuppertal GmbH
city: Würzburg
country: Germany
facility: Universitätsklinik und Poliklinik
Study officials:
affiliation: University Hopsital Tübingen
name: Claus Garbe, MD
role: STUDY_DIRECTOR
affiliation: Johannes Wesling Klinikum Minden
name: Rudolf Stadler, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.