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

University Hospital Tuebingen483 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

483

Conditions

Melanoma

Interventions

Completion Lymphadenectomy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (41)

Humboldt-Universität Berlin Charité

Berlin, Germany

Krankenhaus Neukölln

Berlin, Germany

Universtitäts-Hautklinik Bochum

Bochum, Germany

Zentralkrankenhaus

Bremen, Germany

Universität Köln

Cologne, Germany

Carl-Thiem Klinikum

Cottbus, Germany

Outcomes

Primary Outcomes

Distant metastases free survival

Time frame: 3 Years

Secondary Outcomes

Distant metastases free survival

Time frame: 5 Years