Condition category
Cancer
Date applied
10/07/2014
Date assigned
10/07/2014
Last edited
12/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Joshua Savage

ORCID ID

http://orcid.org/0000-0003-0599-0245

Contact details

Cancer Research UK Clinical Trials Unit
School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
SPOT@trials.bham.ac.uk

Additional identifiers

EudraCT number

2013-000893-32

ClinicalTrials.gov number

Protocol/serial number

16962

Study information

Scientific title

Squamous cell carcinoma prevention in organ transplant recipients using topical treatments: a feasibility study (SPOT)

Acronym

SPOT Trial

Study hypothesis

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

13/LO/1579; First MREC approval date 17/02/2014

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

5% w/w 5-fluorouracil cream (Efudix®), 5% imiquimod cream (Aldara®)

Primary outcome measures

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 trial start date

01/12/2014

Overall trial end date

01/12/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

Participant 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

Recruitment start date

01/12/2014

Recruitment end date

01/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cancer Research UK Clinical Trials Unit
School of Cancer Studies University of Birmingham Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

Queen Mary University of London (UK)

Sponsor details

R&D Office
Barts & London School of Medicine
The QMI building
5 Walden Street
London
E1 2EF
United Kingdom
-
sponsorsrep@bartshealth.nhs.uk

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

MEDA Pharmaceuticals Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NIHR (UK) - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0110-21244

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish protocol, trial results and translational sub-study results.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes