SCC-After

Trial Info

Status: Open

Specialty: Skin

Date Opened: 31/03/25

Planned Close Date: 01/01/2031

Sponsor: NIHR South West Central RRDN

Principal Investigator: Mr Ken McAlister

Study 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.

Trial Description

Cutaneous squamous cell carcinoma (cSCC) is a common skin cancer and high-risk cases (defined as BWH staging system T2b/3) are usually cured by surgery. Unfortunately, it is estimated that 1 in 3 of these patients may develop recurrent disease in the surgical site or nearby lymph glands (loco-regional recurrence) which can lead to significant morbidity, impaired quality of life and mortality attributable to cSCC. Currently, it is not well established if treating high-risk patients with adjuvant radiotherapy (ART) after their surgery leads to better outcomes. Our feasibility work confirmed clinical equipoise around the best approach for standard of care, which differs between clinicians and hospital trusts. The SCC-AFTER trial aims to definitively show whether giving ART plus close clinical follow up (versus close clinical follow up alone) is beneficial in reducing loco-regional recurrence of high-risk primary cSCC following surgery. The outcomes from this study will hopefully provide robust and reliable evidence to guide future national treatment recommendations and improve patient outcomes.

Inclusion Criteria

1) High-risk primary cSCC (T2b/T3 by BWH staging criteria) excised with adequate peripheral and deep surgical margins (according to BAD guidelines) with histologically clear margins (≥1mm by RCPath criteria). ^

2) Time since excision surgery < 3 months (or < 4 months if necessary but < 3 months is preferred).

3) Eastern Co-operative Oncology Group (ECOG) performance status of ≤3 at enrolment.

4) 18 years and older at time of consent.

5) Fit for ART and able to attend radiotherapy outpatient appointments.

6) Life expectancy > 6 months.

7) Informed Consent obtained* which must be prior to any mandatory study-specific procedures, sampling, and analyses.

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 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 (primary end point).

9) History of another malignancy where metastasis could cause diagnostic uncertainty or patients receiving active systemic anticancer treatment (excluding hormonal treatment for prostate or breast cancer) or radiotherapy.

Contacts

Research Nurse: Iram Asif (Iram.Asif@elht.nhs.uk)

Oncology.researchteam@elht.nhs.uk

Link to EDGE

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