The Sentinel Lymph Node Biopsy study is a randomised, feasibility study investigating the diagnosis and treatment of early lymph node involvement in patients with primary cutaneous melanoma by sentinel lymph node biopsy with or without completion lymphadenectomy and molecular markers.
Disease site: Melanoma
Treatment modality: Surgery
Status: In active follow-up
Primary Aim of the feasibility study is to determine patient acceptance of randomisation and compliance with the allocated surgery. Secondary Aims are to compare overall survival and disease-free survival in patients randomised to complete lymphadenectomy with that of patients in the observation arm. Approximately 120 patients will need to be approached in order to randomise 24 with a positive sentinel lymph node. Patients are recruited from 4 participating centres in the UK.
The SLNB Study is co-ordinated by the ICR - Clinical Trials & Statistics Unit and is supported by the NCRI Melanoma Clinical Studies Group.
The Study commenced September 2002 and is expected to close to recruitment Autumn 2006.
Chief Investigator: Dr Tim Eisen, Royal Marsden Hospital NHS Foundation
ICR-CTSU Scientific Lead: Professor Judith Bliss
Trial management contact: [email protected]
Funding: Cancer Research UK
Further information on the SLNB trial may be found on the following sites:
View SLNB on the National Institute for Health Research website: NIHR - Be Part Of Research
Patient friendly information on the SLNB trial at CancerHelp UK