NCT02434107 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2022-12-21

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility 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
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Completion Lymphadenectomy and monitoring afterwards
intervention Names
Procedure: Completion Lymphadenectomy
label
Completion Lymphadenectomy
type
EXPERIMENTAL
description
Monitoring only
intervention Names
Procedure: Clinical Monitoring (Palpation and node ultrasound)
label
Clinical Monitoring (Palpation and node ultrasound)
type
EXPERIMENTAL

interventions

arm Group Labels
Completion Lymphadenectomy
name
Completion Lymphadenectomy
type
PROCEDURE
arm Group Labels
Clinical Monitoring (Palpation and node ultrasound)
name
Clinical Monitoring (Palpation and node ultrasound)
type
PROCEDURE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 483
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Distant metastases free survival
time Frame
3 Years

secondary Outcomes

measure
Distant metastases free survival
time Frame
5 Years

Full study description

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.

Source references

references

citation
Leiter U, Stadler R, Mauch C, Hohenberger W, Brockmeyer NH, Berking C, Sunderkotter C, Kaatz M, Schatton K, Lehmann P, Vogt T, Ulrich J, Herbst R, Gehring W, Simon JC, Keim U, Verver D, Martus P, Garbe C; German Dermatologic Cooperative Oncology Group. Final Analysis of DeCOG-SLT Trial: No Survival Benefit for Complete Lymph Node Dissection in Patients With Melanoma With Positive Sentinel Node. J Clin Oncol. 2019 Nov 10;37(32):3000-3008. doi: 10.1200/JCO.18.02306. Epub 2019 Sep 26.
pmid
31557067
type
DERIVED
citation
Leiter U, Stadler R, Mauch C, Hohenberger W, Brockmeyer N, Berking C, Sunderkotter C, Kaatz M, Schulte KW, Lehmann P, Vogt T, Ulrich J, Herbst R, Gehring W, Simon JC, Keim U, Martus P, Garbe C; German Dermatologic Cooperative Oncology Group (DeCOG). Complete lymph node dissection versus no dissection in patients with sentinel lymph node biopsy positive melanoma (DeCOG-SLT): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):757-767. doi: 10.1016/S1470-2045(16)00141-8. Epub 2016 May 5.
pmid
27161539
type
DERIVED

Source notices and limitations

Discovery and provenance

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sentinel lymph node tumor >1 mm in diameter) that would benefit from a complete lymph node dissection.</li></ul></div></li><li>The <a href="/clinicaltrials/NCT02434107">DeCOG-SLT</a> trial (NCT02434107) included 483 patients with primary melanoma and microscopically detected nodal metastases. Patients were randomly assigned
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m in diameter) that would benefit from a complete lymph node dissection.</li></ul></div></li><li>The <a href="/clinicaltrials/NCT02434107">DeCOG-SLT</a> trial (NCT02434107) included 483 patients with primary melanoma and microscopically detected nodal metastases. Patients were randomly assigned to undergo either completion lymph
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r a sentinel lymph node tumor diameter >1 mm) that would benefit from a complete lymph node dissection.</li></ul></div></li><li>The <a href="/clinicaltrials/NCT02434107">DeCOG-SLT</a> trial (NCT02434107) included 483 patients with primary melanoma and microscopically detected nodal metastases. Patients were randomly assigned
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eter >1 mm) that would benefit from a complete lymph node dissection.</li></ul></div></li><li>The <a href="/clinicaltrials/NCT02434107">DeCOG-SLT</a> trial (NCT02434107) included 483 patients with primary melanoma and microscopically detected nodal metastases. Patients were randomly assigned to undergo completion lymphadenect
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source title
Melanoma Treatment (PDQ®)–Health Professional Version
source update dates
context
Updated: May 2, 2025
datetime
2025-05-02T12:00:00Z
display
May 2, 2025
source url
https://www.cancer.gov/types/skin/hp/melanoma-treatment-pdq

Preserved source evidence · Not medical advice