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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434107
Recruitment Status : Active, not recruiting
First Posted : May 5, 2015
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Melanoma Procedure: Completion Lymphadenectomy Procedure: Clinical Monitoring (Palpation and node ultrasound) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 558 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2005
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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)



Primary Outcome Measures :
  1. Distant metastases free survival [ Time Frame: 3 Years ]

Secondary Outcome Measures :
  1. Distant metastases free survival [ Time Frame: 5 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434107


Locations
Show Show 41 study locations
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Study Director: Claus Garbe, MD University Hopsital Tübingen
Study Chair: Rudolf Stadler, MD Johannes Wesling Klinikum Minden
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02434107    
Other Study ID Numbers: V1410112004
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Keywords provided by University Hospital Tuebingen:
Sentinel Lymph Node Biopsy
Lymph Node Excision
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas