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 a primary invasive cutaneous melanomas \>=1mm thick to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life in patients
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
A wide local excision involves removing an extra "safety margin" of healthy skin surrounding the original melanoma site to ensure that any remaining scattered melanoma tumour cells are removed that may have been left behind after the first initial biopsy/surgery.
A wide local excision involves removing an extra "safety margin" of healthy skin surrounding the original melanoma site to ensure that any remaining scattered melanoma tumour cells are removed that may have been left behind after the first initial biopsy/surgery.
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Melanoma Institute Australia - Poche Centre
North Sydney, New South Wales, Australia
Gold Coast Melanom Clinic
Coolangatta, Queensland, Australia
Peter MacCallum Cancer Centre Division of Cancer Surgery
Melbourne, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Sunnybrook Health Sciences Centre
Toronto, Canada
Sahlgrenska University Hospital
Gothenburg, Sweden
Hull and East Yorkshire Hospitals NHS Trust
Hull, England, United Kingdom
Guy's and St Thomas' Hospital NHS Trust
London, England, United Kingdom
The Christie NHS Foundation Trust
Manchester, England, United Kingdom
...and 10 more locations
Local Melanoma Recurrence (Melanoma Specific Survival)
Time from randomisation to clinically, histologically or radiologically confirmed local recurrence of melanoma including satellite lesions and in transit metastases to regional draining lymph nodes.
Time frame: 0-120 months
Recurrence-Free Survival
Time from randomisation to any clinical, histological or radiologically confirmed melanoma recurrence or death from any cause.
Time frame: 0-120 months
QoL and neuropathic pain assessments Neuropathic Pain (PainDetect)
Quality of Life
Time frame: Baseline, 3, 6 12, 24 & 60 months.
Overall Survival
Time from randomisation to death from any cause.
Time frame: 0-120 Months
Adverse events
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a treatment which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavourable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the treatment timing, whether or not considered related to the treatment. An AE is any adverse change (developing or worsening) from the participant's pre-treatment condition, including intercurrent illness. AEs and any pre-existing medical conditions will be recorded at the Baseline assessment and routinely at Follow Up, until the participant completes the study, withdraws or dies.
Time frame: Within 1 year
Surgery related adverse events
The following surgical adverse events will be recorded from the time of trial treatment to 30 days following the wide excision (inclusive): * wound separation * seroma/haematoma at wide local excision site * haemorrhage * infection * skin graft failure * necrosis of flap used for reconstruction * deep venous thrombosis * urinary tract infection * pneumonia * cardiac complications
Time frame: Up to 30 days from randomisation
Health System Resource Use
All hospitalisations and other interventions will be captured in order to measure resource use.
Time frame: Baseline, 3, 6, 12, 24 and 60 months
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