None listed
Conditions
Brief summary
Who is it for? You may be eligible for the study if you are 70 years or older and have a past history of two or more keratinocyte cancers (BCC or SCC) with at least one on lower limbs( histologically confirmed disease). Alternatively, a past history of one or more keratinocyte cancers and multiple keratotic lesions on the lower limbs. Study details All participants will be randomly assigned (50/50 chance) treatment on one of their legs. The treatment will involve VMAT radiation treatment targeted to the skin cancer. The treatment will occur in two separate segments. The first segment will deliver 10-12 radiation fractions over 2 - 2.5 weeks. This will be followed by a mandatory mid-treatment break of at least 2 weeks (extended up to 4 weeks if necessary). The second treatment segment will deliver the remainder of the 25 fractions (13 - 15 fractions, depending on the number of prior fractions delivered) over 2.5 - 3 weeks. The other leg will serve as the control leg and will not receive any treatment. The overall treatment period will last no longer than 10 weeks. Participants will then be required to attend follow up visits 28 days, 3 months, 6 months, 9 month, 12 months, 18 months and 24 months after the end of treatment. During the study participants will answer questions about their Skin Pain and Quality of life. Benefits of this study The findings from this study will help medical researchers understand how radiation treatment with VMAT may help prevent skin cancers on people who have a high likelihood of disease recurrence.
Interventions
Volumetric modulated arc therapy (VMAT) irradiation.
VMAT will be deliver a total dose of 45 Gy in 25 fractions (1.8 Gy per fraction per day). Only one of two legs of an individual participant will receive VMAT treatment. The untreated leg will serve as the comparator/control.
The treatment will occur in two separate segments. The first segment will deliver 10-12 radiation fractions over 2 - 2.5 weeks. This will be followed by a mandatory mid-treatment break of at least 2 weeks (extended up t
Volumetric modulated arc therapy (VMAT) irradiation. VMAT will be deliver a total dose of 45 Gy in 25 fractions (1.8 Gy per fraction per day). Only one of two legs of an individual participant will receive VMAT treatment. The untreated leg will serve as the comparator/control. The treatment will occur in two separate segments. The first segment will deliver 10-12 radiation fractions over 2 - 2.5 weeks. This will be followed by a mandatory mid-treatment break of at least 2 weeks (extended up to 4 weeks if necessary). The second treatment segment will deliver the remainder of the 25 fractions (13 - 15 fractions, depending on the number of prior fractions delivered) over 2.5 - 3 weeks. The delivery of each daily fraction will take approximately 20 minutes. Treatments will occur only on weekdays between 9 am - 5 pm. Qualified radiation therapists will administer the intervention. The overall treatment period will last no longer than 10 weeks. The GenesisCare Skin Cancer Reference Group will oversee the quality assurance of the VMAT within the trial to ensure the safety and consistency of radiotherapy delivery at treatment site. Prior to inclusion in the trial, individual centres will demonstrate they have robust procedures in place to ensure the appropriate VMAT guidelines are met. Patient specific pre-treatment quality assurance (QA) is required for all VMAT cases and must show a pass result before delivery of the first fraction. In vivo dosimetry is required for all VMAT limb cases and should be performed at or before fraction three to verify that the delivered dose is within 10% of the prescription dose
Sponsors
GenesisCare
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed