Usefulness of Post-Operative Radiotherapy in High-grade Cutaneous Squamous Cell Carcinoma: an Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cutaneous Squamous Cell Carcinoma (CSCC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Post-operative radiotherapy (PORT) is currently considered as the second most important therapy to treat high-grade cutaneous squamous cell carcinoma. Nonetheless, only few studies evaluate its impact on recurrence rate and the major part of those ones do not include a proper control group of patients. Most recent guide lines from NCCN, Sidemast and British associations of dermatologists suggest clinicians to offer or consider PORT in selected patients but class nor level of evidence of those guide lines are provided. This project evaluates impact of post-operative radiotherapy on recurrence rate and overall survival by comparing two cohort of patients, the former who accepted PORT and the latter who, nonetheless its necessity, decided to not undergo it. The hypothesis which this project will answer concerns the effectiveness of post-operative radiotherapy in preventing local and regional recurrences. We expect a significant decrease of recurrence rate in patients who undergo this therapeutic option as compared to those with clinical indication but do not undergo PORT.
Primary outcome measures
- effectiveness of post-operative radiotherapy in preventing local and regional recurrences [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- diagnosis of high-grade cutaneous squamous cell carcinoma
- patients eligible for post-operative radiotherapy
- minimum follow-up of 24 months
Exclusion criteria
- lack of clinical of histological data
- impossibility of a proper follow-up
- occurrence of intermediate events (i.e., pregnancy)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Policlinico San Matteo, SC Dermatologia — Pavia
Identifiers
NCT: NCT06879964 · PORTSCC