{"registry": "ISRCTN", "registryId": "ISRCTN80116429", "source": "https://www.isrctn.com/ISRCTN80116429", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN80116429/format/default", "fetchedAt": "2026-10-07T17:01:30.978192Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "SPOT-IT: prevention of the cutaneous squamous cell carcinoma in immunosuppressed patients using topical treatment", "scientificTitle": "SPOT-IT: cutaneous SCC Prevention using tOpical Therapy in Immunosuppressed patienTs", "acronym": "SPOT-IT", "hypothesis": "•\tTo establish whether 5% 5-Fluorouracil (5FU) topical treatment (comparator: standard of care sunscreen + surveillance) is effective in prevention of cutaneous SCC (cSCC) in immunosuppressed individuals in terms of time to new cSCC development within intervention zones (Phase III)\n\n•\tTo establish whether 5FU and calcipotriol ointment (5FU+CAL) combination therapy (comparator: 5% 5-Fluorouracil (5FU) topical treatment) is effective in prevention of cutaneous SCC (cSCC) in immunosuppressed individuals in terms of time to new cSCC development within intervention zones (embedded Phase II trial)\n\n•\tTo establish whether combination 5FU and calcipotriol ointment is superior to standard of care in prevention of cSCC within intervention zones in immunosuppressed individuals\n•\tTo evaluate the impact of treatment on subsequent cSCC accrual within and outside intervention zones\n•\tThe time to any new primary cSCC outside intervention zones\n•\tThe time to and accrual of other non-cSCC skin cancers within and outside intervention areas\n•\tTo evaluate the time to onset, severity and time to resolution of local skin toxicity associated with each topical treatment \n•\tTo assess other adverse events\n•\tTo evaluate whether 5FU+CAL combination therapy had higher acceptability and lower severity of local skin toxicity compared with 5FU monotherapy\n•\tTo evaluate participants’ experience and preference for each topical treatment and its effects on quality of life\n•\tTo assess the cost-effectiveness of each topical treatment based on the incremental cost per quality-adjusted life year gained", "primaryOutcome": "Time from randomisation to new primary cSCC arising in any of the three selected intervention zone(s): 1) neck, shawl, ± non-hair bearing scalp; 2) face and ears; 3) upper limbs measured using data recorded from randomisation to the time when a new primary cSCC is observed", "secondaryOutcome": "1.\tMore effective treatment will be assessed in terms of time to new cSCC development within intervention zones from randomisation.\n2.\tThe impact of treatment of subsequent cSCC within and outside the intervention zone(s) will be evaluated in terms of time to onset and number of cSCC and non-cSCC skin cancers.\n3.\tLocal skin toxicity associated with each topical treatment from time to onset to resolution will be assessed through the collection of AEs, radiotherapy details, and concomitant medications as reported by clinicians on CRF and by participants on logbooks. \n4.\tParticipants’ experience and preference for each topical treatment will be assessed through logbooks throughout the trial and quality of life (QoL) questionnaires on Day 1 and month 4 of each treatment year, and at least annually for up to 4 years of follow-up.\n5.\tTreatment’s effect on quality of life will be assessed through clinical reported clinical frailty on Day 1 of treatment in Y2-3 and at least annually for up to 4 years follow-up.\n6.\tCost-effectiveness of each topical treatment will be assessed through the QoL questionnaire and Resource use questionnaire on Day 1 and month 4 of each treatment year, and at least annually for up to 4 years of follow-up.", "intervention": "\n\tSPOT-IT Participants will be randomised to one of the following trial treatments:\nSunscreen + 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.\n\n5FU 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. \n\nParticipants will be asked to follow the treatment schedule in the following order:\nNeck, shawl, ± non-hair bearing scalp for 4 weeks (weeks 1-4)\nFace and ears for 4 weeks (weeks 5-8)\nUpper limbs for 4 weeks (weeks 9-12)\nThe 5FU will be applied for a total of 12 weeks without any break between the intervention zones above.\n\nIf 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.\n\n5FU + 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 following order:\n1.\tNeck, shawl, ± non-hair bearing scalp for 6 days, followed by a 1-day break\n2.\tFace and ears for 6 days, followed by a 1-day break\n3.\tUpper limbs for 6 days\n\nIf 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.\n\nParticipants in the 5FU monotherapy arm or in the 5FU + CAL combination arm will be instructed to apply sunscreen at least 1 hour after the morning treatment with 5FU or 5FU + CAL if engaging in outdoor activities.\n\nFollow-up: After trial treatment and clinical assessments in Year 3, or earlier if treatment is discontinued before Year 3, participants will be followed up until the closure of the trial or up to 4 years, depending on the date of the participant’s enrolment into the trial.\n\nRandomisation: Eligible patients will be randomised via the trial SPOT-IT web-based system to one of the three trial arms above. All screening data must be available and entered onto REDCap before randomisation. When the randomisation is completed, the system will confirm whether the participant has been allocated to the Standard of care (sunscreen + surveillance), 5FU monotherapy or 5FU+CAL combination arm. All data entry will be via Electronic Data Capture (EDC).\n\tDrug\n\tPhase III\n\t5FU [5-Fluorouracil] , CAL [Calcipotriol]\n      ", "condition": "\n\tCutaneous 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.\n\tCancer\n\t\n      ", "studyDesign": "Randomized controlled study", "overallEndDate": "2031-12-31T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2026-04-23T14:59:55.656801172Z", "eligibility": {"inclusion": "To be eligible for participation in this trial, the patient must:\n1.\tHave 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)\n2.\tHave history of at least one cSCC in the last 5 years\n3.\tBe willing and able to provide written informed consent for the trial\n4.\tBe willing and able to adhere to study procedures\n5.\tAge 18 years or over on day of signing consent\n6.\tFor Organ Transplant Recipients (OTR): have stable transplanted organ function (transplant duration > 2 years) for at least 3 months prior to enrolment in the trial\n7.\tNo change in immunosuppressive medication in 3 months prior to enrolment in the trial", "exclusion": "1. Is unsuitable for treatment with topical 5FU or calcipotriol e.g. previously intolerant\n2. Known disorders of calcium metabolism, including hypercalcaemia, or any condition that may predispose to elevated serum calcium levels\n3. Known DPD (dihydropyrimidine dehydrogenase) deficiency \n4. Severe renal or liver impairment\n5. 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\n6. Has started treatment with mTOR inhibitors or systemic retinoids within 6 months prior to enrolment \n7. Is participating in a clinical study with other Investigational Medicinal Products \n8. Is pregnant or breastfeeding or planning to conceive or fathering children within the projected duration of the trial", "ageRange": "Mixed", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2026-02-01T00:00:00.000Z", "recruitmentEnd": "2030-01-31T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "673", "totalFinalEnrolment": "0"}, "countries": ["United Kingdom", "Wales"], "locations": [{"name": "Cardiff University", "city": "Cardiff", "state": "", "country": "Wales", "zip": "CF14 4YS"}], "sponsors": [{"organisation": "Cardiff University", "sponsorType": "University/education", "rorId": "https://ror.org/03kk7td41"}], "funders": [{"name": "Cancer Research UK", "fundRef": "http://dx.doi.org/10.13039/501100000289"}]}, "studySha256": "1ae6ad7b957ddff3a6bb560eea2da84f3863a41da5c4e144ae17c5afd70b98e0"}