SCC-AFTER

Adjuvant radiotherapy in patients with high-risk primary cutaneous Squamous Cell Carcinoma after surgery: an open label, multicentre, two-arm phase III randomised trial.

Cutaneous squamous cell carcinoma (cSCC) is a common skin cancer. In most cases it can be cured by surgery, however it can reappear in the skin where it started and/or in nearby lymph glands. This recurrence happens in about 1 in 3 people with cSCCs that are larger, have involved the nearby nerves, and/or, grown beyond the fat layer of the skin (referred to as “high-risk cSCCs”). Patients whose cSCC reappears can experience a big reduction in their quality of life.

Recurrence after surgery is often due to skin cancer cells being unknowingly left behind or cancer cells breaking away into the surrounding skin. Extra treatment such as radiotherapy to the area where the cancer was removed might destroy any remaining cancer cells, however we are not sure if this definitely helps prevent cSCC from reappearing. Despite this, some hospitals are using radiotherapy to treat high-risk cSCC after surgery.

This study aims to answer the question of whether radiotherapy is helpful and better than not using radiotherapy for reducing recurrence of high-risk cSCC after surgery. Following surgery participants with a high-risk cSCC will be randomly allocated to either:

• a course of radiotherapy and close clinical follow-up;
• close clinical follow-up alone.

Both are current treatment options within the NHS for cSCC.

We will monitor all patients for cancer recurrence, treatment side effects and quality of life. If our study shows radiotherapy is effective in preventing recurrence of cSCC, we will be able to recommend its use as a routine NHS treatment.

Approximately 840 patients will be recruited to the study and will be conducted across 25 UK centres.