Title
A Phase III, Multi-Centre, Multi-National Randomised Control Trial Investigating 1CM v 2CM Wide Excision Margins for Primary Cutaneous Melanoma

Description
This study will determine whether there is a difference in disease-free survival rates for patients with primary cutaneous melanoma with Breslow thickness > 2mm or 1-2mm with ulceration (pT2b-pT4b, AJCC 8th edition), treated with either a 1cm excision margin or 2cm margin. 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. If the study shows no risk of 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.

Objective
Primary Objective:

The primary objective of the trial is to assess whether there is no difference in disease-free survival for patients treated with a 1cm excision margin when compared to a 2cm margin for stage II primary melanomas (AJCC 8th edition; pT2b-pT4b)

Secondary objectives:

We hope to show that we can reduce the risk of long-term pain. If the study shows no difference in the risk of tumour recurrence then we will also be able to determine how much of an impact the narrower excision makes to patients in terms of improving QOL and reducing side effects. We will also have enough to data to determine the economic impact of narrower excision margins on the health services and society in general.

Treatment Procedure: Wide Local Excision = 1cm Margin
Procedure: Wide Local Excision = 2cm Margin

Key Eligibility

Patients must have a stage II primary invasive cutaneous melanoma with Breslow thickness >2mm without ulceration), or >1mm (with ulceration only) (pT2b-pT4b, AJCC 8th edition) as determined by diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent histopathological analysis.

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

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

Surgery (which refers to the staging sentinel node biopsy and wide local excision as these are both to be done on the same day) must be completed within 120 days of the original diagnosis.

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

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

Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.

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

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.

Applicable Disease Sites
Melanoma/Skin cancer

Participating Institutions
UW Health University Hospital