| Source of record | UK Trials |
| ISRCTN | ISRCTN13411879 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | ICR/MELANOMA |
| Public title | Randomised trial of width of surgical excision of thick cutaneous malignant melanoma |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Malignant melanoma |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 30/04/1998 |
| Anticipated end date | 31/05/2001 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Quality of life |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Not provided at time of registration |
| Sponsor name | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Sponsor details | MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Sponsor telephone | +44 (0) 20 7670 4723 |
| Sponsor fax | +44 (0) 20 7670 4818 |
| Sponsor email | register@ctu.mrc.ac.uk |
| Sponsor website | http://www.ctu.mrc.ac.uk/ukcccr/home.html |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN13411879 |
| Date last extracted from ISRCTN register | 17/04/2008 |
