None listed
Conditions
Brief summary
Phase 2 This is a study of the effectiveness and toxicity of chemoradiation therapy for skin cancer (squamous cell carcinoma). Who is it for? You can join this study if you have squamous cell skin cancer that cannot be treated surgically. Trial details Participants will receive chemotherapy with the drugs cisplatin or carboplatin once per week for 6 weeks as well as daily radiotherapy. There is no control group in this study. Participants' response to treatment will be measured 8 weeks after treatment is completed. Side effects will be monitored during treatment, at 4, 8 and 12 weeks after treatment is completed, and then every 2 months for the first year, and every three months after that. Overall survival and disease free survival will be measured after 3 years. The study aims to document the effectiveness and toxicity of treatment with combined chemotherapy and radiotherapy.
Interventions
Cisplatin 40mg/m2 given intravenously once per week concurrent with radiation therapy for 6 weekly doses
Carboplatin at a dose of AUC2 given intravenously once a week for 6 weekly doses concurrent with radiotherapy, for patients where cisplatin is contraindicated
Sponsors
Michelle Nottage
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to -2147483648 No limit
Healthy volunteers
No
Inclusion criteria
Patients with cutaneous squamous cell carcinoma with locally-advanced disease at the primary site +/-nodal metastases, or advanced regional node metastases of presumed skin origin. Disease deemed unsuitable for surgical resection
Exclusion criteria
Co-morbid conditions precluding safe administration of trial therapy Previous chemo- or radiotherapy to head and neck region precluding re-treatment Pregnancy/lactation
Outcome results
None listed