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)

December 16, 2022 updated by: University Hospital Tuebingen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

483

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Humboldt-Universität Berlin Charité
      • Berlin, Germany, 12351
        • Krankenhaus Neukölln
      • Bochum, Germany, 44791
        • Universtitäts-Hautklinik Bochum
      • Bremen, Germany, 28205
        • Zentralkrankenhaus
      • Cottbus, Germany, 03048
        • Carl-Thiem Klinikum
      • Darmstadt, Germany, 64297
        • Städtische Kliniken Darmstadt
      • Dessau, Germany, 06847
        • Städtische Kliniken Dessau
      • Dresden, Germany, 01307
        • Universitatsklinikum Carl Gustav Carus
      • Dresden, Germany, 01067
        • Städtisches Klinikum Friedrichsstadt
      • Düsseldorf, Germany, 40225
        • Heinrich Heine Universitat
      • Erfurt, Germany, 99089
        • Klinikum Erfurt GmbH
      • Erlangen, Germany, 91052
        • Universitätsklinikum Erlangen
      • Essen, Germany, 45122
        • Universitätsklinikum Essen
      • Frankfurt/Main, Germany, 60590
        • Klinkum der J. W. Goethe Universität
      • Freiburg, Germany, 79104
        • Klinikum der Albert-Ludwigs-Universität
      • Giessen, Germany, 35385
        • Justus-Liebig-Universitat
      • Göttingen, Germany, 37075
        • Georg-August Universität
      • Hamburg, Germany, 20099
        • Allgemeines Krankenhaus St. Georg
      • Heidelberg, Germany, 69115
        • Klinikum de Ruprecht-Karls-Universität
      • Homburg/Saar, Germany, 66421
        • Universitätsklinikum des Saarlandes
      • Jena, Germany, 07740
        • Klinikum der Friedrich Schiller Universität
      • Karlsruhe, Germany, 76133
        • Städtische Hautklinik Karlsruhe
      • Kassel, Germany, 34125
        • Städtische Kliniken Kassel
      • Köln, Germany, 50924
        • Universität Köln
      • Leipzig, Germany, 04103
        • Universität Leipzig
      • Lemgo, Germany, 32657
        • Klinkum Lippe-Lemgo GmbH
      • Lübeck, Germany, 23538
        • Universitätsklinikum Lübeck
      • Magdeburg, Germany, 39120
        • Otto-von-Guericke-Universität
      • Marburg, Germany, 35033
        • Klinik der Philipps-Universität
      • Minden, Germany, 32429
        • Johannes Wesling Klinikum Minden
      • Munich, Germany, 80337
        • Ludwig-Maximilians-Universität
      • Munich, Germany, 80802
        • Technische Universität
      • Munich, Germany, 80804
        • Städt. Krankenhaus München-Schwabing
      • Münster, Germany, 48149
        • Universitätsklinkum Münster
      • Oldenburg, Germany, 26133
        • Städtische Kliniken Oldenburg
      • Regensburg, Germany, 93053
        • Klinkum der Universität
      • Tübingen, Germany, 72076
        • Eberhard-Karls Universität
      • Ulm, Germany, 89081
        • Universitatsklinikum Ulm
      • Unna, Germany, 59423
        • Katholisches Krankenhaus
      • Wuppertal, Germany, 42117
        • Klinkum Wuppertal GmbH
      • Würzburg, Germany, 97080
        • Universitätsklinik und Poliklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Completion Lymphadenectomy
Completion Lymphadenectomy and monitoring afterwards
Procedure: Completion Lymphadenectomy
Experimental: Clinical Monitoring (Palpation and node ultrasound)
Monitoring only
Procedure: Clinical Monitoring (Palpation and node ultrasound)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distant metastases free survival
Time Frame: 3 Years
3 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Distant metastases free survival
Time Frame: 5 Years
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Study Director: Claus Garbe, MD, University Hopsital Tübingen
  • Study Chair: Rudolf Stadler, MD, Johannes Wesling Klinikum Minden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2005

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 16, 2022

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1410112004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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