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

Cardiff University0 个研究点目标入组 840 人开始时间: 2024年7月2日最近更新: 2024年7月15日

适应症

试验速览

暂无简介。

•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 Royal College of Pathology criteria
•2. Time since excision surgery < 3 months (<2 months is preferred)
•3. ECOG performance status of 3 or less at enrolment
•4. Aged 18 years or 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

•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

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