Intralesional triamcinolone acetonide for squamous cell carcinoma of the lower limbs

Phase 2

Recruiting

• Conditions: Cutaneous squamous cell carcinoma; Cancer - Non melanoma skin cancer

• Registration Number: ACTRN12621000851864
• Lead Sponsor: Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[ 5 weeks after intralesional treatment]