SCC-AFTER Protocol V1.0_07-Nov-2023
Research type
Research Study
Full title
Adjuvant radiotherapy in patients with high-risk primary cutaneous Squamous Cell Carcinoma AFTER surgery (SCC-AFTER): an open label, multicentre, two-arm phase III randomised trial
IRAS ID
331136
Contact name
Agata Rembielak
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Cutaneous squamous cell carcinoma (cSCC) is a common skin cancer. Although cSCC is usually cured by cutting it out surgically, it can reappear in the skin where it started and in the nearby lymph nodes. This is called loco-regional recurrence and it happens in about 1 in 3 people with high-risk cSCCs which are those where the cancer cells look very active under the microscope. Loco-regional recurrence can lead to serious problems such as pain, bleeding, ulceration, infections, disfigurement, loss of physical function, odour, emotional and social distress, and eventually leads to 75% of the deaths caused by cSCC.
Loco-regional recurrence after surgery is often due to skin cancer cells having been unknowingly left behind or having broken away into the surrounding skin. One way to reduce the risk of this happening may be to use extra treatment such as radiotherapy in the area where the cancer was removed so that any remaining cancer cells are destroyed. However, we are not sure if using radiotherapy after surgery definitely reduces the risk of high-risk SCC reappearing.
Finding out whether radiotherapy helps or not is important:
1. To prevent loco-regional recurrence, as once the cancer reappears it is difficult to treat.
2. Because radiotherapy is already used in some hospitals to try to reduce the chances of the cancer from returning from where it was removed.Although radiotherapy could be effective, if it is not effective or if it has too many side effects, then we should stop using it across the NHS. However, if effective it should be recommended more widely across the NHS in this way.
We asked patients and carers and healthcare teams who look after people with cSCC and they all agree that locoregional recurrence is an important problem and that finding out whether radiotherapy helps or not is an important question.REC name
East of England - Essex Research Ethics Committee
REC reference
24/EE/0049
Date of REC Opinion
12 Apr 2024
REC opinion
Further Information Favourable Opinion