Randomised trial of width of surgical excision of thick cutaneous malignant melanoma
| ISRCTN | ISRCTN13411879 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13411879 |
| Protocol serial number | ICR/MELANOMA |
| Sponsor | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Funder | Not provided at time of registration |
- 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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised trial of width of surgical excision of thick cutaneous malignant melanoma |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Quality of life |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 30/04/1998 |
| Date of final enrolment | 31/05/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
