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)

University Hospital Tuebingen

Status: Completed

Conditions: Melanoma

Treatments: Procedure: Completion Lymphadenectomy; Procedure: Clinical Monitoring (Palpation and node ultrasound)

Study type: Interventional

Funder types: Other

Identifiers

NCT02434107

V1410112004

Details and patient eligibility

About

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.

Enrollment: 483 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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483 participants in 2 patient groups

Completion Lymphadenectomy

Experimental group

Description:

Completion Lymphadenectomy and monitoring afterwards

Treatment:

Procedure: Completion Lymphadenectomy

Clinical Monitoring (Palpation and node ultrasound)

Experimental group

Description:

Monitoring only

Treatment:

Procedure: Clinical Monitoring (Palpation and node ultrasound)