Last updated on September 2018

A clinical trial seeking patients for a research study for the treatment of Cutaneous Melanoma by AJCC V7 Stage

Brief description of study

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

Detailed Study Description

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.

Clinical Study Identifier: NCT02385214

Contact Investigators or Research Sites near you

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Melanoma Institute Australia - Poche Centre
North Sydney, Australia

Gold Coast Melanom Clinic
Coolangatta, Australia

Peter MacCallum Cancer Centre Division of Cancer Surgery
Melbourne, Australia

Alfred Hospital
Melbourne, Australia

Hull and East Yorkshire Hospitals NHS Trust
East Yorkshire, United Kingdom

Guy's and St Thomas' Hospital NHS Trust
London, United Kingdom

The Christie NHS Foundation Trust
Manchester, United Kingdom

St Helens & Knowsley NHS Trust
Prescott, United Kingdom

Oxford University Hospitals NHS Trust
Headington, United Kingdom

North Bristol NHS Trust
Bristol, United Kingdom

Mid Essex Hospital Services NHS Trust
Essex, United Kingdom

Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom

St. James University Hospital
Leeds, United Kingdom

Royal Free London NHS Foundation Trust
London, United Kingdom

Norfolk and Norwich University Hospital
Norwich, United Kingdom