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

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

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.

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