Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
10/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- - -

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

UK Co-ordinating Committee for Cancer Research (UKCCCR)

Sponsor details

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

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes