MelmarT Melanoma Margins Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma

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. The study is designed to be able to prove or
disprove that there is no difference in risk of the tumour recurring around the scar or
anywhere else in the body between the two groups of patients. This study is designed to show
that the risk of long-term pain associated with surgery can be halved. If the study shows no
risk of the tumour recurrence then we will also be able to determine how much of an impact
the narrower excision has on patients in terms of improved quality of life and reduced side
effects from the surgery and melanoma disease. This trial will also evaluate and determine
the economic impact of narrower excision margins on the health services and society in
general.

Inclusion Criteria:

1. Patients must have a primary invasive cutaneous melanoma of Breslow thickness greater
than 1 millimetre as determined by diagnostic biopsy (narrow excision, incision or
punch biopsy) and subsequent histopathological analysis.

2. Patients must have had the invasive primary completely excised, including any in situ
component but excluding melanocytic atypia, with a narrow margin, either in one stage
or more than one stage in the case where an incision or punch biopsy has previously
been performed. This information, including measured margins of lateral and deep
clearance must be documented on the pathology report.

3. Must have a primary melanoma that is cutaneous (including head, neck, trunk,
extremity, scalp, palm, sole).

4. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary
melanoma.

5. Randomisation and the primary study intervention, including staging sentinel node
biopsy, must be completed by 120 days of original diagnosis.

6. Patients must be 18 years or older at time of consent.

7. Patient must be able to give informed consent and comply with the treatment protocol
and follow-up plan.

8. Life expectancy of at least 10 years from the time of diagnosis, not considering the
melanoma in question, as determined by the PI.

9. Patients must have an ECOG performance score between 0 and 1.

10. A survivor of prior cancer is eligible provided that ALL of the following criteria are
met and documented:

- The patient has undergone potentially curative therapy for all prior
malignancies,

- There has been no evidence of recurrence of any prior malignancies for at least
FIVE years (except for successfully treated cervical or non-melanoma skin cancer
with no evidence of recurrence), and

- The patient is deemed by their treating physician to be at low risk of recurrence
from previous malignancies.

Exclusion Criteria:

1. Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown
malignant potential'.

2. Patient has already undergone wide local excision at the site of the primary index
lesion.

3. Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the
primary index lesion.

4. Desmoplastic or neurotropic melanoma.

5. Microsatellitosis as per AJCC 2009 definition

6. Subungual melanoma

7. Patient has already undergone a local flap reconstruction of the defect after excision
of the primary and determination of an accurate excision margin is impossible.

8. History of previous or concurrent (i.e., second primary) invasive melanoma.

9. Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the
eyelids or on the ear, mucous membranes or internal viscera.

10. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit,
regional, or distant metastatic melanoma.

11. Patient has undergone surgery on a separate occasion to clear the lymph nodes of the
probable draining lymphatic field, including sentinel lymph node biopsy, of the index
melanoma.

12. Any additional solid tumour or hematologic malignancy during the past 5 years except
T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine/cervical
cancer.

13. Melanoma-related operative procedures not corresponding to criteria described in the
protocol.

14. Planned adjuvant radiotherapy to the primary melanoma site after Wide Local Excision
is not permitted as part of the protocol and any patients given this treatment would
be excluded from the study.

15. History of organ transplantation.

16. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any
time during study participation or within 6 months prior to enrolment.