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Trial registered on ANZCTR


Registration number
ACTRN12621000851864
Ethics application status
Approved
Date submitted
17/05/2021
Date registered
1/07/2021
Date last updated
1/07/2021
Date data sharing statement initially provided
1/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Intralesional triamcinolone acetonide for squamous cell carcinoma of the lower limbs
Scientific title
Investigating the effect of intralesional triamcinolone acetonide on the size of cutaneous squamous cell carcinomas in elderly adults with squamous cell carcinoma of the lower limbs
Secondary ID [1] 304235 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous squamous cell carcinoma 321938 0
Condition category
Condition code
Cancer 319666 319666 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intralesional triamcinolone acetonide (TAC; 40mg/mL) for cutaneous squamous cell carcinomas (cSCCs) affecting the lower limb in elderly patients. TAC will be administered in clinic as a single injection by dermatologists and melanoma surgeons to a maximum volume of 1mL depending on tumour size.
Intervention code [1] 320567 0
Treatment: Drugs
Comparator / control treatment
Intralesional normal saline. This will be administered in clinic as a single injection by dermatologists and melanoma surgeons to a maximum volume of 1mL (dependent on tumour size)
Control group
Placebo

Outcomes
Primary outcome [1] 327538 0
Size of cSCCs (mean of two perpendicular diameters) 5 weeks after administration of intralesional TAC or placebo (normal saline). All tumour measurements will be performed in two perpendicular diameters using measurement calipers (to 0.2mm; John Bull). Photographs of treated tumours including a measurement scale will also be taken.
Timepoint [1] 327538 0
5 weeks after intralesional treatment
Secondary outcome [1] 395587 0
Effect of punch biopsy on tumour size. All tumour measurements will be performed in two perpendicular diameters using measurement calipers (to 0.2mm; John Bull). Photographs of tumours including a measurement scale will also be taken before biopsy and immediately before TAC or saline injection to assess this secondary outcome.
Timepoint [1] 395587 0
2 weeks post diagnostic biopsy to confirm SCC; injection of TAC or saline will then be done at this 2 week visit following the 2 week measurements.
Secondary outcome [2] 395592 0
Grade of cSCCs that are later biopsied or excised. This will be determined as per standard histopathology assessment by specialist histopathologists, as per standard clinical practice.
Timepoint [2] 395592 0
5 weeks post intralesional injection
Secondary outcome [3] 395595 0
Safety and tolerability (adverse events). Potential adverse effects include erosion at treatment site (identified by participant self report and review at study visits and at interim visits as appropriate). Allergic local reaction to the injected steroid is rare, but would be identified by participant self report and review at study visits and at interim visits as appropriate. We do not anticipate other adverse effects.
Timepoint [3] 395595 0
5 weeks post intralesional injection
Secondary outcome [4] 395596 0
Effect on Lower Extremity Functional Scale ( J. M. Binkley et al. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network, Physical therapy, 1999, 79, 371-383).
Timepoint [4] 395596 0
5 weeks post intralesional injection
Secondary outcome [5] 395601 0
Quality of life; EORTC QLQ-C30 QoL survey ( N. K. Aaronson et al., The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology, J Natl Cancer Inst, 1993, 85, 365-376).
Timepoint [5] 395601 0
5 weeks post intralesional injection

Eligibility
Key inclusion criteria
1. Aged 70 years or older
2. Lower limbs clinically deemed to be high risk for wound healing (including but not limited to diabetes mellitus; chronic venous disease changes affecting the lower limb; lipodermatosclerosis; history of lower limb cellulitis; history of poor wound healing on lower legs; lower limb oedema)
3. Potential participants must have at least one lesion on the legs clinically consistent with low-grade SCC. Biopsy would be taken (3mm punch) as per standard clinical practice. If confirmed to be SCC, the tumour(s) must be histologically proven primary low-grade cutaneous SCC of the lower limb
4. Low-grade tumours must have zero high-risk factors as per Brigham and Women’s Hospital Tumour Staging system for cSCC. These risk factors include:
- Diameter greater than or equal to 2cm
- Poorly-differentiated histology
- Perineural invasion greater than or equal to 0.1mm
- Tumour invasion beyond fat
5. Patient agreeable to delay in surgical excision. It should be noted that the 5 week duration of the trial falls within usual time to excision of well-differentiated cSCC on the lower limbs in the clinics which is 1-2 months.
6. Willingness and ability to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Histologically proven cSCC that are moderately or poorly differentiated
2. Unable to follow up for the duration of the study due to frailty, geographical or social reasons
3. Known contraindication to injection of triamcinolone acetonide (such as hypersensitivity to ingredients).
4. Patient prefers surgical excision
5. Patient undertaking other treatment for the lesion or lesions (such as field treatments, radiotherapy, photodynamic therapy)
6. Immune suppression (including transplant recipients, chronic haematological malignancies, immune-suppressive medications for autoimmune disorders)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment; sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After consent and enrolment, eligible lesions will be randomised in a 1:1 ratio to intervention or control groups. For this small participant group, randomisation will be done via a blocked randomisation list, stratified by gender (Sealed Envelope Ltd. 2020: https://www.sealedenvelope.com/simple-randomiser/v1/lists).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19459 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 34051 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 308613 0
University
Name [1] 308613 0
Prof Diona Damian; University of Sydney
Address [1] 308613 0
Dermatology, Gloucester House 3, University of Sydney at Royal Prince Alfred Hospital, Missenden Rd, Camperdown NSW 2050
Country [1] 308613 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Level 11 KGV Building Missenden Road CAMPERDOWN NSW2042
Country
Australia
Secondary sponsor category [1] 309481 0
None
Name [1] 309481 0
Address [1] 309481 0
Country [1] 309481 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308545 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 308545 0
Suite 210A RPAH Medical Centre, Carillon Avenue Newton NSW 2042
Ethics committee country [1] 308545 0
Australia
Date submitted for ethics approval [1] 308545 0
Approval date [1] 308545 0
31/03/2021
Ethics approval number [1] 308545 0
X20-04645 - 2020/STE04660

Summary
Brief summary
This study aims to determine whether injection of a corticosteroid (triamcinolone acetonide) directly into squamous cell carcinoma (SCC) lesions of elderly patients (older than 70) is safe and whether this drug has any effect on the size of the lesions.

Who is it for?
You may be eligible for this study if you are aged 70 or older, you have at least one lesion on either of your legs clinically consistent with low-grade SCC, and you have been deemed to be at high risk of surgical complications because of pre-existing lower limbs conditions (such as diabetes mellitus, chronic venous disease affecting the lower limbs, previous lower leg cellulitis, previous poor wound healing at the legs, lower limb oedema).

Study details
All participants who choose to enrol in this study will undergo a biopsy of one or more of their SCC lesions to determine the severity of the lesion and whether they are eligible to enrol in this study. Two weeks after this biopsy, eligible participants will be randomly allocated by chance (similar to flipping a coin) to have one or more of their SCC lesions injected with either the corticosteroid drug or a placebo (sterile injection solution). Participants who have more than one eligible lesion may have different injections administered to different lesions, this decision will be made by the treating doctor. A maximum of one injection to each eligible lesion will be made over a 5 week period. Prior to this injection and after the last review at 5 weeks, all participants will be asked to complete two questionnaires about their lower limb function and quality of life. These questionnaires are anticipated to take 20 minutes. No further study visits will be required after the 5 weeks.

It is hoped this research will demonstrate that corticosteroid injection into SCC lesions is safe and able to reduce the size of the lesions, which may then be used to improve health outcomes for future patients with SCC.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111086 0
Prof Diona Damian
Address 111086 0
Dermatology, GH3, Royal Prince Alfred Hospital, Missenden Rd Camperdown NSW 2050
Country 111086 0
Australia
Phone 111086 0
+61 2 9515 8295
Fax 111086 0
+612 9565 1048
Email 111086 0
diona.damian@health.nsw.gov.au
Contact person for public queries
Name 111087 0
Prof Diona Damian
Address 111087 0
Dermatology, GH3, Royal Prince Alfred Hospital, Missenden Rd, Camperdown NSW 2050
Country 111087 0
Australia
Phone 111087 0
+61 2 9515 8295
Fax 111087 0
+612 9565 1048
Email 111087 0
diona.damian@health.nsw.gov.au
Contact person for scientific queries
Name 111088 0
Prof Diona Damian
Address 111088 0
Dermatology, GH3, Royal Prince Alfred Hospital, Missenden Rd Camperdown NSW 2050
Country 111088 0
Australia
Phone 111088 0
+61 2 9515 8295
Fax 111088 0
+612 9565 1048
Email 111088 0
diona.damian@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results