The SCC-AFTER research study aims to find out whether it is better to use radiotherapy or not to prevent high-risk skin cancer from coming back after it has been removed by surgery
- Conditions
- Adjuvant radiotherapy in patients with high-risk primary cutaneous Squamous Cell Carcinoma AFTER surgeryCancer
- Registration Number
- ISRCTN54806122
- Lead Sponsor
- Cardiff University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 840
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method oco-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 Outcome Measures
Name Time Method