SPOT-IT: cutaneous SCC Prevention using tOpical Therapy in Immunosuppressed patienTs
Cutaneous Squamous cell carcinoma (SCC) is a type of skin cancer. Some SCC may develop from areas of sun-damaged skin called actinic keratoses (AK), which arise on skin areas exposed to sunlight.
SPOT-IT Participants will be randomised to one of the following trial treatments: Sunscreen + surveillance: Sunscreen with sun protection factor (SPF) 50+ will be applied daily as per the PI’s recommendations and the participant’s requirements. In this trial, sunscreen is not defined as an IMP. 5FU monotherapy: SPOT-IT Participants allocated to the 5FU monotherapy arm will be asked to apply a thin layer of 5FU cream to the affected area twice a day for 4 weeks sequentially to each of the three intervention zones. Participants will be asked to follow the treatment schedule in the following order: Neck, shawl, ± non-hair bearing scalp for 4 weeks (weeks 1-4) Face and ears for 4 weeks (weeks 5-8) Upper limbs for 4 weeks (weeks 9-12) The 5FU will be applied for a total of 12 weeks without any break between the intervention zones above. If the participant has no hair at their temples beyond hairline recession, this area should be treated as part of their face. If an AK occurs on the parting area of the hair, it is recommended to treat this area with 5FU as intervention zone no. 1. In either case, treatment will be discussed and agreed, by participants and PI. This schedule will be repeated annually for 3 years and on day 1 of Years 2 and 3 (± 6 weeks window). The total dose of 5FU should not be greater than an area of 500cm2 (23x23cm) at a time. 5FU + CAL combination: Trial participants randomised to the 5FU+CAL arm will be required to apply a thin layer of 5FU cream to the intervention zone(s) and left to absorb (5 minutes). Calcipotriol ointment should then be applied to the same intervention zone(s) in the same quantity. This combination should be applied twice a day for 6 days, followed by a 1-day treatment break, sequentially to each of the intervention zones. This schedule will be repeated annually for 3 years. The maximum weekly dose of CAL ointment is 100g and should not be exceeded, as hypercalcaemia may occur. Participants will be asked to follow the follo
To be eligible for participation in this trial, the patient must: 1. Have a diagnosis of immunodeficiency being either organ or stem cell transplant recipient; haematological malignancy; long-term immunosuppressive medication for immune mediated inflammatory condition; living with human immunodeficiency virus infection (HIV) 2. Have history of at least one cSCC in the last 5 years 3. Be willing and able to provide written informed consent for the trial 4. Be willing and able to adhere to study procedures 5. Age 18 years or over on day of signing consent 6. For Organ Transplant Recipients (OTR): have stable transplanted organ function (transplant duration > 2 years) for at least 3 months prior to enrolment in the trial 7. No change in immunosuppressive medication in 3 months prior to enrolment in the trial
1. Is unsuitable for treatment with topical 5FU or calcipotriol e.g. previously intolerant 2. Known disorders of calcium metabolism, including hypercalcaemia, or any condition that may predispose to elevated serum calcium levels 3. Known DPD (dihydropyrimidine dehydrogenase) deficiency 4. Severe renal or liver impairment 5. Has used topical 5FU or calcipotriol or other actinic keratosis (AK)-field treatment in the planned treatment zone within 8 weeks prior to enrolment in the trial 6. Has started treatment with mTOR inhibitors or systemic retinoids within 6 months prior to enrolment 7. Is participating in a clinical study with other Investigational Medicinal Products 8. Is pregnant or breastfeeding or planning to conceive or fathering children within the projected duration of the trial