Adjuvant radiotherapy in patients with high-risk primary cutaneous Squamous Cell Carcinoma (a non-melanoma skin cancer) after surgery Cancer
Conditions
Interventions
This study aims to find out whether using radiotherapy in people who have had high-risk skin cancer removed by surgery reduces the chances of their skin cancer coming back, or whether radiotherapy is
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 20/08/2026: 1. High-risk primary cSCC (T2b/T3 by BWH staging criteria) excised with histologically clear peripheral and deep margins (=1 mm by RCPath criteria). Surgical excision margins should be consistent with BAD guidelines (peripheral and deep) and will be recorded. If, after surgical excision with curative intent (either wide local excisions with predetermined margins or Mohs micrographic surgery) the deep histological margin is 6 months 7. Informed Consent obtained* which must be prior to any mandatory study-specific procedures, sampling, and analyses * Patients should be provided with additional support and adjustments where needed (e.g., layering of information, involvement of a family member/friend as a support person, provide witnessed informed consent if unable to confirm informed consent in writing). Note: this will include those patients who are elderly, frail and have multiple long-term chronic conditions who are a group at particular risk for cSCC. It will also include immunocompromised patients who are excluded from most clinical trials but have high rates of cSCC. Previous inclusion criteria as of 18/02/2026: 1. High-risk primary cSCC (T2b/T3 by BWH staging criteria) excised with histologically clear peripheral and deep margins (=1 mm by RCPath criteria*). Surgical excision margins should be consistent with BAD guidelines (peripheral and deep) and will be recorded. 2. Time since excision surgery 6 months 7. Informed Consent obtained** which must be prior to any mandatory study-specific procedures, sampling, and analyses *For SCC on the scalp, a deep histological margin of 0.8 mm - 6 months 7. Informed Consent obtained
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 20/08/2026: 1. Any current clinicopathological evidence of loco-regional recurrence of the index tumour 2. Previous (within 2 years) or current non-index primary cSCC in skin drained by the same lymph node basin** 3. cSCC on anatomical sites which interfere with suitability for ART (such as vermilion lip, eyelids, breast, anogenital area) 4. Patients with evidence of regional or distant disease at time of primary cSCC diagnosis 5. Previous radiotherapy to the same area 6. Patients with reproductive potential who are not willing to use contraception for the duration from trial consent until the last dose of radiotherapy if they are randomised to the ART arm. 7. Unable to lie still unattended for the duration of ART (estimated to be around 5 minutes) 8. Participation in another interventional clinical study that may affect the recurrence of cSCC 9. History of another malignancy where metastasis could cause diagnostic uncertainty or patients receiving active systemic anti-cancer treatment (excluding hormonal treatment for prostate or breast cancer) or radiotherapy*** **Please consider discussing all patients with multiple cSCC draining to the same nodal basin as the index cSCC with the SCC-After trial team including those within the last 3 years. ***Please discuss patients with malignancy of concern with the SCC-After trial team Previous exclusion criteria: 1. Any current clinicopathological evidence of loco-regional recurrence of the index tumour 2. Previous (within 3 years) or current non-index primary cSCC in skin drained by the same lymph node basin 3. cSCC on anatomical sites which interfere with suitability for ART (such as vermilion lip, eyelids, breast, anogenital area) 4. Patients with evidence of regional or distant disease at time of primary cSCC diagnosis 5. Previous radiotherapy in the same area 6. Patients with reproductive potential who are not willing to use contraception for the duration from trial consent until the last dose of radiotherapy if they are randomised to the ART arm 7. Unable to lie still unattended for the duration of ART (estimated to be around 5 minutes) 8. Participation in another interventional clinical study that may affect the recurrence of cSCC (primary endpoint) 9. History of another malignancy where metastasis could cause diagnostic uncertainty or patients receiving active systemic anti-cancer treatment (excluding hormonal treatment for prostate or breast cancer) or radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Loco-regional recurrence (LRR)-free survival time, time to LRR is defined as the time from randomisation to date of clinical detection of what is subsequently confirmed to be local, regional, or loco-regional recurrent disease, measured using physical examination at a skin clinic at 4, 8, 16, 12, 24, and 36 months following randomisation until the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life (QOL) measured using EORTC QLQ C30, skin-specific Skin Cancer Index, Picker Patient Experience 15 questionnaire and EQ-5D at 4, 12, 24, and 36 months post-randomisation 2. Distant metastasis-free survival, defined as days from randomisation to the date of distant metastasis or death from any cause, measured using data reported by completion of recurrence CRF from randomisation until the point of recurrence is confirmed or death 3. Overall survival, defined as days from randomisation to death for any reason, measured using data reported by completion of a death CRF at the date of death 4. Safety/toxicity as assessed by common terminology criteria for adverse events (CTCAE) V5.0 scoring system and serious adverse events, including patient-reported outcomes version of the CTCAE, measured using adverse event CRFs at 4, 8, 16, 24, 26 months post-randomisation 5. Cost-effectiveness measured using health utility using EQ-5D-5L and recording health resource use at 4, 12, 24, and 36 months post-randomisation. The primary economic outcome is cost per quality-adjusted life year (QALY). The secondary economic outcome is resource use and costs. | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactAnn White
Outcome results
None listed