Background. There is a lack of definitive evidence regarding optimal surgical excision margins for primary cutaneous melanoma > 1 mm in Breslow thickness (BT). A narrower surgical margin is expected to be associated with lower morbidity, improved quality of life (QoL), and reduced cost. This study is a continuation of a feasibility study already published1 and is currently in progress.
Methods. This Phase III, multicentre trial administered by Melanoma and Skin Cancer Trials randomise patients with primary cutaneous melanoma > 1 mm in BT to a 1 cm versus 2 cm wide excision margin to be performed with sentinel lymph node biopsy. Surgical closure technique is at the discretion of the treating surgeon. Patients’ QoL is measured at baseline, 3, 6, 12 and 24 months after randomisation. The target accrual is 2,998 patients over a 5-year period.
Results. Four sites are actively recruiting; two in Australia (Peter MacCallum Cancer Centre and Melanoma Institute Australia/Royal Prince Alfred Hospital), one in Sweden (Sahlgrenska University Hospital) and USA (Rutgers Cancer Institute of New Jersey). A total of 22 patients are randomised thus far: 20 in Australia, 1 each in Sweden and USA. Approximately, 35 sites have commenced start-up activities and researchers in 14 countries have expressed interest to participate in the study.
Discussion. The successful completion of the pilot study demonstrates the feasibility of a large international randomised control trial to provide a definitive answer to the optimal excision margin for patients with intermediate to high-risk primary cutaneous melanoma. The results from this study will define the standard of care for surgical management of T2b-T4 primary cutaneous melanoma for the foreseeable future.