A trial looking at treatment for basal cell skin cancer (SINS)

Please note this trial is no longer recruiting patients.

This trial is comparing surgery with imiquimod (Aldara) for basal cell skin cancer.

Basal cell skin cancer (also called basal cell carcinoma or BCC) is the most common form of skin cancer. It usually grows slowly, and rarely spreads. BCCs are often removed with surgery.

Imiquimod (Aldara) is a cream that stimulates the immune system. This means it uses the bodys natural defences to kill the cancer cells in the skin.

The aim of this trial is to compare surgery and imiquimod for the treatment of superficial and nodular BCC. The doctors hope that imiquimod will work as well as surgery, and so patients in future will not have to have an operation to remove their BCC.

Recruitment

Start 30/05/2003

End 22/02/2007

Phase

Phase 3

Who can enter

You can enter this trial if you

Have superficial or nodular basal cell skin cancer (BCC)
Will be in the UK for at least 3 years for follow up

You cannot enter this trial if you

Have any other serious medical condition
Are taking part in any other clinical trial
Do not have access to a telephone
Are pregnant or breastfeeding

Trial design

This trial will recruit about 700 patients. It is a randomised trial. The trial has 2 groups. The people taking part will be put into a group by a computer.

Group 1 will have surgery to remove the BCC. Group 2 will have imiquimod to remove their BCC. If the imiquimod does not work, the BCC will be removed with surgery.

Hospital visits

If you are put into group 1, you will have surgery to remove your BCC as soon as possible. The time you will have to wait will vary slightly between hospitals, but should be within a few months. The operation is often done under local anaesthetic and you can go home the same day.

Someone from the hospital will phone you 2 weeks later to check that everything is ok. You will see a nurse or doctor at the hospital at 6 weeks, 12 weeks, 18 weeks, 6 months, 1 year, 2 years and 3 years.

If you are put into group 2, you will need to apply the imiquimod cream once a day. Your doctor will assess your BCC and decide how many weeks you should apply the cream for. This will probably be about 6 weeks for superficial BCC and about 12 weeks for nodular BCC.

Someone from the hospital will phone you after 2 weeks to check that everything is ok. You will see a nurse or doctor at the hospital at 6 weeks, 12 weeks, 18 weeks, 6 months, 1 year, 2 years and 3 years. There is a telephone helpline number at the hospital for you to call if you are worried about anything while you are on the trial.

The research team will give you a diary which you will need to fill out while you are having treatment, and for 16 weeks afterwards.

Side effects

You might get some soreness or redness where you are applying the imiquimod cream. If you are concerned about any side effects, you can call the telephone helpline for information and advice.