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

Not Applicable

Completed

• Conditions: Melanoma

• Registration Number: NCT02434107
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-05-05
• Status Verified: 2017-05
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 483

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Distant metastases free survival	3 Years

Secondary Outcome Measures

Name	Time	Method
Distant metastases free survival	5 Years

Trial Locations

Locations (41)

Humboldt-Universität Berlin Charité; 🇩🇪 Berlin, Germany

Krankenhaus Neukölln; 🇩🇪 Berlin, Germany

Universtitäts-Hautklinik Bochum; 🇩🇪 Bochum, Germany

Zentralkrankenhaus; 🇩🇪 Bremen, Germany

Carl-Thiem Klinikum; 🇩🇪 Cottbus, Germany

Städtische Kliniken Darmstadt; 🇩🇪 Darmstadt, Germany

Städtische Kliniken Dessau; 🇩🇪 Dessau, Germany

Städtisches Klinikum Friedrichsstadt; 🇩🇪 Dresden, Germany

Universitätsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Germany

Heinrich Heine Universität; 🇩🇪 Düsseldorf, Germany

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