A Phase III, multi-centre, multi-national randomised control trial investigating 1cm v 2cm wide excision margins for primary cutaneous melanoma on disease recurrence and survival.

This study will determine whether there is a difference in local recurrence rates and melanoma survival rates for patients treated with either a 1cm excision margin or 2cm margin for both intermediate & high risk melanomas.

Who is it for?
You may be eligible to joint this study if you aged 18 years or above and have been diagnosed with a primary invasive cutaneous melanoma greater than 1mm thick.

Study details
Whilst patients with a primary invasive melanoma are generally recommended to undergo excision of the primary lesion with a wide margin, there is evidence that less radical margins of excision may be just as safe. Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will undergo surgery with the 2cm excision margin, whilst participants in the other group will undergo surgery with a 1cm excision margin.

Participants will be monitored for up to 60 months, in order to determine melanoma recurrence, survival rates and quality of life, and additionally, adverse events and health resource usage.

Intervention

This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with a primary invasive cutaneous melanomas >=1mm thick to determine differences in the rate of local recurrence and melanoma specific survival.

ARM A: Experimental Arm
Wide Local Excision = 1cm Margin
+ Sentinel Lymph Node Biopsy
+/- Reconstruction
These procedures need to be performed +<14 days from the date of randomisation.

Comparator

ARM B:Control Arm
Wide Local Excision = 2cm Margin
+ Sentinel Lymph Node Biopsy
+/- Reconstruction
These procedures need to be performed +<14 days from the date of randomisation.

RSTN involvement

Mr Marc Moncrieff is leading this pilot study in the UK. It is now open to recruitment and so units interested should get in touch with him via his website.

Further trial information is available on the main MelMarT website.