Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICR/MELANOMA
Study information
Scientific title
Randomised trial of width of surgical excision of thick cutaneous malignant melanoma
Acronym
Study hypothesis
This national randomised prospective trial is designed to establish the optimal surgical margins of excision of melanomas with a Breslow thickness 2 mm or larger. It compares recurrence and survival in two groups of patients: those whose melanomas were excised with a 1 cm margin of normal skin (requiring only out-patient surgery) or with a 3 cm margin (usually requiring in-patient surgery, skin grafting and admission for up to one week). The quality of life in the two groups will be assessed after surgery and during follow up. The feasibility of this trial has been demonstrated by the success of the pilot phase in which 170 patients have been entered from 41 participating centres.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Malignant melanoma
Intervention
Two surgical options are available:
A. PROPOSED STUDY:
The primary melanoma is locally excised with a 1 mm margin of macroscopically normal skin. Within 45 days of initial surgery patients are randomised to:
1. Group A: Surgery, re-excision with a 1 cm margin.
2. Group B: Surgery, re-excision with a 3 cm margin.
B. ALTERNATIVE STUDY:
The primary melanoma is locally excised (wide excision) with a 1 cm margin of macroscopically normal skin. Within 45 days of initial surgery patients are randomised to:
1. Group C: Surgery, re-excision with a further 2 cm margin.
2. Group D: No further treatment.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Quality of life
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/04/1998
Overall trial end date
31/05/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged over 18 years
2. Single primary localised melanoma of depth 2 mm or greater
3. Melanoma must not be located on head, neck, fingers, toes, soles of feet or palms of hands (patients with melanomas on dorsum of hands and feet are eligible)
4. No prior history of other malignancies, except basal cell carcinoma
5. Not receiving immunosuppressive therapy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
30/04/1998
Recruitment end date
31/05/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list