Squamous cell carcinoma prevention in organ transplant recipients using topical treatments
| ISRCTN | ISRCTN26398197 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26398197 |
| EudraCT/CTIS number | 2013-000893-32 |
| Secondary identifying numbers | 16962 |
- 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
Contact information
Mrs Yolande Jefferson-Hulme
Scientific
Scientific
Cancer Research UK Clinical Trials Unit
Institute of Cancer and Genomic Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| SPOT@trials.bham.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 5% w/w 5-fluorouracil cream (Efudix®), 5% imiquimod cream (Aldara®) |
| Primary outcome measure | Proportion of patients who would be willing to use the treatment again; Timepoint(s): Month 15 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/12/2014 |
| Completion date | 03/07/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 120; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
Cancer Research UK Clinical Trials Unit
School of Cancer Studies
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor information
Queen Mary University of London (UK)
University/education
University/education
R&D Office
Barts & London School of Medicine
The QMI building
5 Walden Street
London
E1 2EF
England
United Kingdom
| sponsorsrep@bartshealth.nhs.uk | |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Industry
MEDA Pharmaceuticals Ltd (UK)
No information available
NIHR (UK) - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0110-21244
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We intend to publish protocol, trial results and translational sub-study results. |
| 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 |
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.
