None listed
Conditions
Brief summary
The purpose of this trial is to see if a reduced radiotherapy can deliver equivalent treatment response to full dose radiotherapy for patients with skin cancer. Who is it for? You may be eligible for this study if you are aged 50 or older and have non-melanoma skin cancer. Study details Participants in this group will receive one of two treatments. This is determined by patient preference and medical officer recommendation. Both groups will have the reduced radiotherapy dose for 5 weeks, either as five doses per week with a week between treatment weeks; or as 3 doses per week for 5 weeks. Both groups will receive the same dose. The purpose of this trial is to see if a reduced radiotherapy can deliver equivalent treatment response to full dose radiotherapy for patients with skin cancer. A total of 100 participants will be recruited with the study across selected GenesisCare Sites within Australia. It is anticipated that it will take 36 months to complete the accrual of 100 participants. All participants will be followed for another 12 months after the end of accrual, giving the trial a total duration of 48 months (4 years).
Interventions
Volumetric modulated arc therapy (VMAT) radiation: a total dose of 30 Gy will be delivered in 15 fractions as either
1) 2 Gy per fraction (10 Gy in 5 fractions), 5 days per week, treated alternate weeks over a period of 5 weeks OR
2) 2 Gy per fraction treated 3 times per week, over 5 weeks
The treatment schedule is determined by participant preference and/or investigator decision.
Sponsors
GenesisCare
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be aged 50 years or greater; 2. Have ESFC greater than 50 cm2; 3. Provide written informed consent; and 4. Fulfil at least two of the following three criteria (a, b, c): a. Karnofsky performance score of less than or equal to 70; b. Be unable to complete a fully fractionated, long-course of treatment due to a comorbidity or the requirement for nursing home care; c. Be aged greater than or equal to 70 years 5. Charlson Comorbidity Score greater than or equal to 5 6. 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
Exclusion criteria
1. Received local therapy within the last 4 weeks. This includes excision, cryotherapy, photo-dynamic therapy, radiotherapy or topical agents including 5FU, imiquimod ingenol mebutatte. 2. Have a clinically or biopsy-proven invasive skin malignancy within the treatment field to be treated which has either been untreated, or incompletely excised within the last 6 months 3. Currently receiving systemic chemotherapy or treatment with new targeted drugs (e.g. immunotherapy, tyrosine kinase inhibitors or BRAF inhibitors); 4. Are concurrently using radio sensitising drugs for medical comorbidities (e.g. methotrexate for rheumatoid arthritis, hydroxyurea etc); 5. For patients who are having lower limbs treated and have any of the following: • Chronic lymphoedema with pitting oedema, peripheral vascular disease in the form of intermittent claudication or critical ischemia • Chronic leg ulcer within the proposed treatment field • Relapsing cellulitis 6. Have received prior radiotherapy to the same treatment site or 7. Any other medical condition as defined by the investigator which significantly impacts the patient’s involvement and suitability in this study
Outcome results
None listed