Squamous cell carcinoma prevention in organ transplant recipients using topical treatments

ISRCTN	ISRCTN26398197
DOI	https://doi.org/10.1186/ISRCTN26398197
Clinical Trials Information System (CTIS)	2013-000893-32
Protocol serial number	16962
Sponsor	Queen Mary University of London (UK)
Funders	MEDA Pharmaceuticals Ltd (UK), NIHR (UK) - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0110-21244

Submission date: 10/07/2014
Registration date: 10/07/2014
Last edited: 28/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/trials/a-study-looking-treatment-prevent-skin-cancer-people-who-have-had-organ-transplant-spot

Contact information

Mrs Yolande Jefferson-Hulme
Scientific

Cancer Research UK Clinical Trials Unit
Institute of Cancer and Genomic Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	SPOT@trials.bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Squamous cell carcinoma prevention in organ transplant recipients using topical treatments: a feasibility study (SPOT)
Study acronym	SPOT Trial
Study objectives	A multi-centre, randomised, three arm, open-label, phase ll, feasibility study comparing topical treatment of actinic keratoses (AK) in Organ Transplant Recipients (OTR) using 5-fluorouracil or 5% imiquimod (plus sunscreen) to standard care (sunscreen alone) in the prevention of squamous cell carcinoma (cSCC). The main objective of this study is to establish the feasibility of performing a phase III randomised controlled trial evaluating prevention of cSCC using currently available topical interventions. On 10/12/2014 the following changes were made to the trial record: 1. The overall trial start date was changed from 01/08/2014 to 01/12/2014. 2. The overall trial end date was changed from 01/08/2015 to 01/12/2016.
Ethics approval(s)	13/LO/1579; First MREC approval date 17/02/2014
Health condition(s) or problem(s) studied	Topic: Cancer, Dermatology; Subtopic: Melanoma, Skin (all Subtopics); Disease: Skin, Dermatology
Intervention	1. 5% w/w 5-fluorouracil cream (Efudix®), with discretionary sunscreen as per standard care, for 4 weeks (Treatment Cycle 1), followed by a 4-week resting period and then another 4-week treatment phase (Treatment Cycle 2). Topical treatment will be applied to the chosen treatment zone(s) once or twice per day dependent on the site of the AK.; 2. 5% imiquimod cream (Aldara®), with discretionary sunscreen as per standard care, for 4 weeks (Treatment Cycle 1), followed by a 4-week resting period and then another 4-week treatment phase (Treatment Cycle 2). Topical treatment will be applied to the chosen treatment zone(s) overnight for 3 (Mon, Wed, Fri or Tue, Thu, Sat) to 5 times (Mon-Fri) per week dependent on the site of the AK.; 3. Standard care, discretionary sunscreen only (SPF >30), should be applied daily to all exposed areas of the skin at least 30 minutes before sun exposure and topped up as required, from April to October or during high-UVR exposure activities during winter months.
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	5% w/w 5-fluorouracil cream (Efudix®), 5% imiquimod cream (Aldara®)
Primary outcome measure(s)	Proportion of patients who would be willing to use the treatment again; Timepoint(s): Month 15
Key secondary outcome measure(s)	1. Assessment of QoL measure; Timepoint(s): Month 15 2. Clearance of AK; Timepoint(s): End of treatment periods (4 and 8 weeks post treatment) 3. Development of cSCC; Timepoint(s): 12 months post treatment 4. Evaluation of the proposed overall AK quantification scoring criteria; Timepoint(s): Established pre-trial 5. Measure concordance of AK diagnosis by clinicians; Timepoint(s): Month 15 6. Patient treatment preferences; Timepoint(s): Month 15 7. Persistence of clearance of AK; Timepoint(s): End of month 12 8. Proportion of eligible patients who complete treatment cycle 1; Timepoint(s): Week 4 9. Proportion of eligible patients who require & complete treatment cycle 2; Timepoint(s): Week 12 10. Proportion of eligible patients willing to be randomised; Timepoint(s): Randomisation
Completion date	03/07/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Total final enrolment	101
Key inclusion criteria	1. Organ Transplant Recipient (OTR) Patient Group: 1.1. OTRs aged >18 years 1.2. A minimum of 10 AK (with at least 5 AK occurring within the same skin zone) 1.3. Demonstrably stable renal function on the basis of serum creatinine and estimated Glomerular Filtration Rate (eGFR) 1.4. No recent change in immunosuppressive medication and predicted to remain stable over course of the study 1.5. Able to apply topical cream as directed to the required area or having a carer who agrees to do this at the required frequency and times 1.6. Women of childbearing potential, or men in a relationship with a woman of childbearing potential, prepared to adopt adequate contraceptive measures if sexually active 1.7. Able to give written informed consent 1.8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures 2. Immunocompetent Patient Group (participating in the DCE substudy only): 2.1. ICP patients aged >18 years 2.1. Present or previous AK (any site, any number) 2.3. Able to give written informed consent 2.4. Willing to spend up at least 20 minutes completing the Long Q
Key exclusion criteria	Organ Transplant Recipients (OTR) only: 1. Pregnant (female patients of child bearing potential should have a urine or blood Human Chorionic Gonadotropin (hCG) test performed to rule out pregnancy prior to trial entry) 2. Lactating females. Patients who agree to discontinue nursing 14 days prior to commencing treatment and do not nurse throughout all the treatment period are eligible 3. Life expectancy less than 12 months 4. Known hypersensitivity or intolerance to 5-fluorouracil, imiquimod, sunscreen, or to any of the excipients (including but not limited to: methylhydroxybenzoate, propylhydroxybenzoate, cetyl alcohol, stearyl alcohol, polysorbate 60, propylene glycol, methyl parahydroxybenzoate and white soft paraffin) 5. The use of brivudine, sorivudine and analogues is prohibited
Date of first enrolment	01/12/2014
Date of final enrolment	01/12/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Cancer Research UK Clinical Trials Unit

School of Cancer Studies
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results			28/05/2020	No	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

28/05/2020: Added clinicaltrialsregister.eu link to basic results (scientific).
07/04/2020: The following changes have been made:
1. The scientific contact has been updated.
2. The overall trial end date has been changed from 01/12/2016 to 03/07/2018.
3. The total final enrolment number has been added.