Title: A clinical study of wide excision alone versus wide excision with intraoperative lymphatic mapping and Sentinel Lymph Node Dissection in the treatment of patients with cutaneous invasive melanoma.

Lay Summary: The standard treatment for malignant melanoma is a wide local excision.  This means the surgical removal of additional skin and tissue around the site of the primary (original) melanoma.  It is done to make sure that the entire lesion is removed and to minimise the risk of recurrence in the area.

The purpose of this study is to compare surgical treatment options for primary melanoma.  These options are:

• a wide local excision only, or
• a wide local excision plus intraoperative lymphatic mapping and selective lymph node removal.

This study will enable us to evaluate the effect upon the overall and disease-free survival by identifying patients who may benefit by more aggressive surgery at the time they are diagnosed using the selective lymph node biopsy technique. 

Designed for patients with Clark level III and Breslow thickness 1.00mm or greater, or patients with Clark level IV or greater (regardless of Breslow thickness) this trial randomly assigned patients to either the wide excision of the primary site alone, or a combination of wide excision plus selective lymphadenectomy (SLND). If the selective procedure demonstrated positive (tumour-containing) lymph nodes a complete lymph node dissection was performed. Prior to the development of the selective procedure, the only treatment option was a complete lymph node dissection and removing all the lymph nodes. This complete procedure, may only help about 20% of people. Patients entered in the trial are currently being followed up with the specific aim of determining if there is a difference in overall survival by either of the treatment arms and determine best practice treatment in reducing known complications from complete lymph node dissections by offering it only to those patients who would benefit from more aggressive surgery.

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