This trial is active, not recruiting.

Condition melanoma
Treatments completion lymphadenectomy, clinical monitoring (palpation and node ultrasound)
Phase phase 2
Sponsor University Hospital Tuebingen
Start date December 2005
End date July 2015
Trial size 558 participants
Trial identifier NCT02434107, V1410112004


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Completion Lymphadenectomy and monitoring afterwards
completion lymphadenectomy
Monitoring only
clinical monitoring (palpation and node ultrasound)

Primary Outcomes

Distant metastases free survival
time frame: 3 Years

Secondary Outcomes

Distant metastases free survival
time frame: 5 Years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by University Hospital Tuebingen.