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

Conditions

Melanoma

Keywords

Sentinel Lymph Node Biopsy, Lymph Node Excision

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.

Ulrike Leiter, Rudolf Stadler, Cornelia Mauch, Werner Hohenberger, Norbert H. Brockmeyer et al. (20 authors)

Journal of Clinical Oncology2019-09-26236 citations

10.1200/jco.18.02306

Final analysis of DECOG-SLT trial: Survival outcomes of complete lymph node dissection in melanoma patients with positive sentinel node.

Ulrike Leiter, Rudolf Stadler, Cornelia Mauch, Werner Hohenberger, Norbert H. Brockmeyer et al. (18 authors)

Journal of Clinical Oncology2018-05-2019 citations

10.1200/jco.2018.36.15_suppl.9501

Complete lymph node dissection versus no dissection in patients with sentinel lymph node biopsy positive melanoma (DeCOG-SLT): a multicentre, randomised, phase 3 trial.

Leiter U, Stadler R, Mauch C, Hohenberger W, Brockmeyer N, Berking C, Sunderkötter 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).

2016-05-05430 citations

10.1016/s1470-2045(16)00141-8

Interventions

PROCEDURECompletion Lymphadenectomy

PROCEDUREClinical Monitoring (Palpation and node ultrasound)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Distant metastases free survival	3 Years

Secondary

Measure	Time frame
Distant metastases free survival	5 Years

Countries

Germany

Outcome results

None listed