Brief Summary
Patients with a primary invasive melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body) are recommended to undergo excisionto surgically remove/cut out 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 lifethe overall well-being of a person diagnosed with cancer, encompassing both physical and emotional aspects of health.
Intervention / Treatment
- Procedure: Wide Local Excisionremoval of cancerous tissue and a margin of healthy tissue around it to prevent cancer recurrence = 1cm Margin
- Procedure: Wide Local Excision = 2cm Margin
Inclusion Criteria:
Patients may be included in the study if they meet ALL of the following criteria:
- 1. Patients must have a Stage II primary invasive cutaneous melanoma (pT2b-pT4b, AJCC 8th edition) with Breslow thickness >1.0mm to 2.0mm; >2.0mm to 4.0mm or >4.0mm with ulceration, or >2.0mm to 4.0mm; or >4.0mm without ulceration (Table 1) as determined by diagnostic biopsyremoval of a section of tissue to analyse for cancer cells (narrow excision, incision, shave 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.
- 4. Surgical intervention (which refers to the stagingthe process of determining how big the cancer is, where it started and if it has spread to other areas -SLNB and WLE as these are both to be done on the same day) must be completed within 120 days of the original diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results. Surgical intervention must also be performed within 28 days of randomisation.
- Patients must be 18 years or older at time of consent.
- Patient must be able to give informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. 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 at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.
- A survivor of prior cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs 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 recurrenceto occur or happen again of any prior malignancies for at least FIVE years (with the exception of successfully treated uterine/cervical or non-melanoma skin cancers (SCCs/BCCs) with no evidence of recurrence), and
- The patient is deemed by their treating physician to be at low riskthe possibility that something bad will happen of recurrence from previous malignancies.