Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Humboldt-Universität Berlin Charité, Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Completion Lymphadenectomy

Procedure

Clinical Monitoring (Palpation and node ultrasound)

Procedure

Primary outcomes

Distant metastases free survival

Time frame: 3 Years

Secondary outcomes

Distant metastases free survival

Time frame: 5 Years

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study 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

Acronym: DeCOG-SLT

Important dates

Study start: 2005
Primary completion: 2017
Study completion: 2017
First posted: May 5, 2015
Registry last updated: Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed