Volumetric Modulated Arc Therapy (VMAT) Irradiation in Skin Cancer Incidence Preventio

Not Applicable

Withdrawn

• Conditions: basal cell carcinoma; squamous cell carcinoma; keratotic skin lesions; Cancer - Non melanoma skin cancer

• Registration Number: ACTRN12619001218189
• Lead Sponsor: GenesisCare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-03
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1.Aged 70 years or older.

2.Has provided written Informed Consent for participation in this trial.

3.Past history of two or more keratinocyte cancers (BCC or SCC) with at least one on lower limbs, Histologically confirmed disease OR past history of one or more keratinocyte cancers and multiple keratotic lesions on the lower limbs.

4.Life expectancy greater than three years.

5.Willing to use adequate contraception measures (both in vivo and in vitro) during and for six months after radiation treatment for participants who will engage in the conception of a child.

6.Available for follow-up for two years.

Exclusion Criteria

1.Previous radiotherapy to either lower limb.

2.Previous field treatment (e.g. Fluorouracil (5-FU), Aldara Picato Photodynamic therapy) to area to be treated in past 12 months.

3.Chronic lymphoedema with pitting oedema, peripheral vascular disease in the form of intermittent claudication or critical ischaemia.

4.Chronic leg ulcer.

5.Relapsing leg cellulitis.

6.Active/untreated keratinocyte cancer (i.e. invasive BCC or SCC) on legs at the time of enrolment.

7.Patients with clinical evidence of metastatic disease from any primary cancer.

8.Solid organ transplant recipient

9.Genetic conditions predisposing to malignancies such as Gorlin Syndrome, Gardner’s syndrome and Fanconi Anaemia.

10.Use of any other systemic cancer therapeutic with significant cutaneous adverse reaction: Fluorouracil (5FU) based chemotherapeutics, epidermal growth factor receptor (EGFR) inhibitors,
immune checkpoint inhibitors, sorafenib, sunitinib and other tyrosine kinase inhibitors. (Patient’s will be considered eligible if they have a 28 day wash out period if these therapeutics are in use)

11.Connective tissue disorders: systemic lupus erythematosus, scleroderma.

12.Known radiation hypersensitivity syndrome and ataxia telangiectasia.

13.Radiosensitising medication including methotrexate

14.Any other condition as defined by the investigator which significantly impact the patient’s involvement and suitability in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of incident histologically proven BCC, SCC and keratotic lesions on the irradiated and control legs of patients with a past history of one or more histologically proven keratinocyte cancers (BCC or SCC) on the lower limbs as assessed by clinical examination.[24 months after completion of radiation therapy]