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Skin SCC-AFTER trial - effect size survey
Introduction
Dear Colleague,
We are planning a trial of adjuvant radiotherapy (ART) for adequately resected high-risk cutaneous SCC (cSCC). We are seeking expert opinion on the likely effect size of ART in reducing risk of cSCC recurrence. The following survey consists of 4 questions and should take no longer than 3 minutes to complete.
Background
SCC-AFTER is a trial in which we are planning to evaluate the role of ART for surgically resected T2b and T3 primary cSCC (staged using Brigham and Women’s Hospital BWH system).
There is no site or age restriction, and patients (including immunocompromised) will be eligible if their relevant MDT deems them to be suitable.
The primary outcome is reduction in rate of loco-regional recurrence (LRR). We have chosen LRR because
· first relapse after primary treatment almost always occurs in the primary site, in transit, or in the regional lymph nodes (or any combination).
· staging systems for SCC do not include local recurrence
Disease-specific survival is a secondary outcome measure.
Radiotherapy schedules agreed for the study will deliver ART to the surgical (primary) site only and this will be planned and delivered as per local standard of care. Acceptable schedules include 45 Gy in 10#, 50-55 Gy in 20# and 60 Gy in 30# (depending on radiotherapy field size and risk of late skin toxicity). The dose fractionation schedules and planning technique will be recorded.
Survey of likely effect size
We have previously surveyed clinicians on what they consider to be the range of effect sizes necessary before they would routinely consider using ART in completely resected cSCC. However, it is unclear what effect size we might actually expect to see with ART and studies published to date do not provide this information.
We would be very grateful if you would consider the questions below.
Many thanks for your help.
Agata Rembielak and Catharine Harwood
on behalf of SCC-AFTER Trial Management Group
If you wish to learn more about SCC-AFTER, please contact Dr Agata Rembielak via agata.rembielak@nhs.net