S2015: MelMarT-II

Patients with a primary invasive melanoma are 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. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

In order to participate you must meet the following criteria:

1. You Have the Right Kind of Skin Cancer
   You must have a serious type of skin cancer called Stage II cutaneous melanoma. It needs to be thick enough and may or may not have ulceration (broken skin).
2. Your Melanoma Is on the Skin
   The cancer must be on your skin (like your head, neck, arms, legs, hands, feet, or back), not inside the body or on mucous membranes.
3. You’re Able to Have Surgery
   You must be able to have the following two procedures, which must be done within 120 days after diagnosis.:
   • A wide local excision (WLE) – to remove the cancer.
   • A sentinel lymph node biopsy (SLNB) – to check if it spread. 
4. You’re an Adult and Can Agree to Join
   You must be 18 or older, able to understand the study, and follow the plan.
5. You’re in Good Health Otherwise
   You must be expected to live at least 5 more years (not counting the melanoma) and be physically well enough to take part (ECOG 0–1).

You will be excluded from the study if any of the following criteria apply to you:

1. You’ve Already Had Major Surgery for This Melanoma
   If you’ve already had a wide local excision or lymph node surgery for this melanoma, you can’t join.
2. You Have a Special Kind of Melanoma
   If your melanoma is a rare type like desmoplastic (over 90% scar-like tissue), subungual (under the nail), or has perineural invasion (spreading along nerves), you aren’t eligible.
3. The Cancer Has Spread Too Far
   If the melanoma has spread to other parts of your body, like nearby skin, lymph nodes, or organs, you can't join.
4. You Have a History of More Than One Invasive Melanoma
   If you’ve had more than one serious melanoma in the past, you're not eligible.
5. You’ve Had Other Cancers or Are Taking Immunosuppressants
   You can't join if you’ve had other cancers in the past 5 years (except some skin or cervical cancers) or if you’re taking immune-suppressing medications.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.