search
Back to results

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)

Primary Purpose

Melanoma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Completion Lymphadenectomy
Clinical Monitoring (Palpation and node ultrasound)
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Sentinel Lymph Node Biopsy, Lymph Node Excision

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Humboldt-Universität Berlin Charité
  • Krankenhaus Neukölln
  • Universtitäts-Hautklinik Bochum
  • Zentralkrankenhaus
  • Carl-Thiem Klinikum
  • Städtische Kliniken Darmstadt
  • Städtische Kliniken Dessau
  • Städtisches Klinikum Friedrichsstadt
  • Universitätsklinikum Carl Gustav Carus
  • Heinrich Heine Universität
  • Klinikum Erfurt GmbH
  • Universitätsklinikum Erlangen
  • Universitätsklinikum Essen
  • Klinkum der J. W. Goethe Universität
  • Klinikum der Albert-Ludwigs-Universität
  • Justus-Liebig-Universität
  • Georg-August Universität
  • Allgemeines Krankenhaus St. Georg
  • Klinikum de Ruprecht-Karls-Universität
  • Universitätsklinikum des Saarlandes
  • Klinikum der Friedrich Schiller Universität
  • Städtische Hautklinik Karlsruhe
  • Städtische Kliniken Kassel
  • Universität Köln
  • Universität Leipzig
  • Klinkum Lippe-Lemgo GmbH
  • Universitätsklinikum Lübeck
  • Otto-von-Guericke-Universität
  • Klinik der Philipps-Universität
  • Johannes Wesling Klinikum Minden
  • Ludwig-Maximilians-Universität
  • Technische Universität
  • Städt. Krankenhaus München-Schwabing
  • Universitätsklinkum Münster
  • Städtische Kliniken Oldenburg
  • Klinkum der Universität
  • Eberhard-Karls Universität
  • Universitätsklinikum Ulm
  • Katholisches Krankenhaus
  • Klinkum Wuppertal GmbH
  • Universitätsklinik und Poliklinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Completion Lymphadenectomy

Clinical Monitoring (Palpation and node ultrasound)

Arm Description

Completion Lymphadenectomy and monitoring afterwards

Monitoring only

Outcomes

Primary Outcome Measures

Distant metastases free survival

Secondary Outcome Measures

Distant metastases free survival

Full Information

First Posted
April 2, 2015
Last Updated
December 16, 2022
Sponsor
University Hospital Tuebingen
search

1. Study Identification

Unique Protocol Identification Number
NCT02434107
Brief Title
Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node)
Acronym
DeCOG-SLT
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2005 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Sentinel Lymph Node Biopsy, Lymph Node Excision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
483 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Completion Lymphadenectomy
Arm Type
Experimental
Arm Description
Completion Lymphadenectomy and monitoring afterwards
Arm Title
Clinical Monitoring (Palpation and node ultrasound)
Arm Type
Experimental
Arm Description
Monitoring only
Intervention Type
Procedure
Intervention Name(s)
Completion Lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
Clinical Monitoring (Palpation and node ultrasound)
Primary Outcome Measure Information:
Title
Distant metastases free survival
Time Frame
3 Years
Secondary Outcome Measure Information:
Title
Distant metastases free survival
Time Frame
5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Garbe, MD
Organizational Affiliation
University Hopsital Tübingen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rudolf Stadler, MD
Organizational Affiliation
Johannes Wesling Klinikum Minden
Official's Role
Study Chair
Facility Information:
Facility Name
Humboldt-Universität Berlin Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Krankenhaus Neukölln
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Universtitäts-Hautklinik Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Zentralkrankenhaus
City
Bremen
ZIP/Postal Code
28205
Country
Germany
Facility Name
Carl-Thiem Klinikum
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Facility Name
Städtische Kliniken Darmstadt
City
Darmstadt
ZIP/Postal Code
64297
Country
Germany
Facility Name
Städtische Kliniken Dessau
City
Dessau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Städtisches Klinikum Friedrichsstadt
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Heinrich Heine Universität
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Klinikum Erfurt GmbH
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinkum der J. W. Goethe Universität
City
Frankfurt/Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Klinikum der Albert-Ludwigs-Universität
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
Facility Name
Justus-Liebig-Universität
City
Giessen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Georg-August Universität
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Allgemeines Krankenhaus St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Klinikum de Ruprecht-Karls-Universität
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Klinikum der Friedrich Schiller Universität
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Städtische Hautklinik Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Städtische Kliniken Kassel
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Universität Köln
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Universität Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinkum Lippe-Lemgo GmbH
City
Lemgo
ZIP/Postal Code
32657
Country
Germany
Facility Name
Universitätsklinikum Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Otto-von-Guericke-Universität
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Klinik der Philipps-Universität
City
Marburg
ZIP/Postal Code
35033
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Ludwig-Maximilians-Universität
City
Munich
ZIP/Postal Code
80337
Country
Germany
Facility Name
Technische Universität
City
Munich
ZIP/Postal Code
80802
Country
Germany
Facility Name
Städt. Krankenhaus München-Schwabing
City
Munich
ZIP/Postal Code
80804
Country
Germany
Facility Name
Universitätsklinkum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Städtische Kliniken Oldenburg
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Klinkum der Universität
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Eberhard-Karls Universität
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Katholisches Krankenhaus
City
Unna
ZIP/Postal Code
59423
Country
Germany
Facility Name
Klinkum Wuppertal GmbH
City
Wuppertal
ZIP/Postal Code
42117
Country
Germany
Facility Name
Universitätsklinik und Poliklinik
City
Würzburg
ZIP/Postal Code
97080
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
31557067
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.
Results Reference
derived
PubMed Identifier
27161539
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.
Results Reference
derived

Learn more about this trial

Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node)

We'll reach out to this number within 24 hrs