Randomised trial of width of surgical excision of thick cutaneous malignant melanoma

ISRCTN ISRCTN13411879
DOI https://doi.org/10.1186/ISRCTN13411879
Secondary identifying numbers ICR/MELANOMA
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
10/03/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

- - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleRandomised trial of width of surgical excision of thick cutaneous malignant melanoma
Study objectivesThis 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMalignant melanoma
InterventionTwo 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 typeProcedure/Surgery
Primary outcome measureQuality of life
Secondary outcome measuresNot provided at time of registration
Overall study start date30/04/1998
Completion date31/05/2001

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment30/04/1998
Date of final enrolment31/05/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Not defined

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan