SCC-AFTER: Management of high risk primary cutaneous SCC in the head and neck region AFTER surgery
We would like to conduct a randomised controlled trial (RCT) of radiotherapy (RT) in the treatment of patients with pT2 and pT3 (‘high risk’) head and neck primary cutaneous squamous cell carcinoma (H&N pcSCC).

This short survey is being sent to Specialist Skin cancer MDTs (SSMDT) and Head and Neck Specialist MDTs (H&N SMDT) across the UK. We would be very grateful for consensus advice from your SMDT about this proposal to help us assess feasibility of this trial. It will take less than 10 minutes to complete.

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Each trial centre must be represented by a single specialist MDT, either a Skin cancer Specialist MDT (SSMDT) OR a Head and Neck Specialist MDT (H&N SMDT).
1. The provisional design is to study 2 groups as outlined below. In principle, would your SSMDT OR H&N SMDT consider randomising patients into this study?
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2. If you would not randomise to either or both, please say why:
3. In your Network where are patients with ‘high-risk’ H&N pcSCC discussed?
4. Roughly how many patients a month with ‘high-risk’ H&N pcSCC are discussed in your SSMDT/H&N SMDT?
5. Does your SSMDT/H&N SMDT already offer adjuvant radiotherapy (ART) to patients with ‘high risk’ H&N pcSCC?
6. Does your SSMDT/H&N SMDT offer radiotherapy (RT) to closely excised (histologically <1mm) H&N pcSCC?
7. Does your SSMDT/H&N SMDT routinely offer sentinel lymph node biopsy to patients with ‘high risk’ H&N pcSCC?
8. In this study we propose using the following ART schedules (determined by size of treatment area):
45 Gy in 10# 50-55 Gy in 20# 60 Gy in 30#
Would you be willing to use these ART schedules?
9. Does your SSMDT/H&N SMDT regard excision complete when pathological margins are ≥ 1mm as per RCPath guidelines?
10. Following surgery, when would you aim to start ART/RT?
11. In this study we will define ‘high-risk’ tumours as T2/3 using TNM 8th edition as outlined below. Additional histological/clinical features will also be considered.
a. Would your SSMDT/H&N SMDT be willing to recruit patients into this study if based on the above TNM 8 staging system alone?
b. Would your SSMDT/H&N SMDT be willing to recruit patients into this study based on the above TNM staging system plus some/all of the additional features?
12. Which of the following CLINICAL factors would influence your SSMDT/H&N SMDT to consider ART for pcSCC? (Select all that apply)
13. Which of the following HISTOLOGICAL factors would influence your SSMDT/H&N SMDT to consider ART for pcSCC? (Select all that apply)
14. Which of the following do you feel should be the primary outcome measure for PART A in this RCT (ART vs no ART)?
15. For patients in PART A without treatment, the absolute risk of loco-regional recurrence is estimated to be 5-10%. What is the minimum treatment effect/risk reduction you would want to see from ART?
16. Which of the following do you feel should be the primary outcome measure for PART B of this study (surgery vs RT)?
17. We do not know the absolute risk for these patients but the consensus is that this will be greater than PART A. What is the minimum treatment effect/risk reduction you would want to see from RT?
18. Would a member of your SSMDT/H&N SMDT be willing to act as Principal Investigator for your centre?
19. We are keen to undertake a SSMDT/H&N SMDT simulation exercise to determine the number of patients with high risk pcSCC who are discussed and to ascertain the feasibility of recruiting eligible patients to this proposed trial. Would you be interested in participating? Please provide your name and email address as contact details if yes.
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Any other comments?
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Thank you for your time!
If you would like any more information about the trial then please contact the Chief Investigator, Agata Rembielak at agata.rembielak@christie.nhs.uk
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