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Clinical Trials in Italy / NCT06879964
Recruiting Observational

Usefulness of Post-Operative Radiotherapy in High-grade Cutaneous Squamous Cell Carcinoma: an Observational Study

NCT06879964 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Phase
Observational
Started
2023-11-17
Last updated
2025-03-17

Condition(s) studied

Cutaneous Squamous Cell Carcinoma (CSCC)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • effectiveness of post-operative radiotherapy in preventing local and regional recurrences — 24 months
    Association of PORT and recurrence rate, considering PORT as a binary variable (yes/no) and evaluating recurrence with a clinical and echographic follow-up with a minimum duration of 24 months.

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Policlinico San Matteo, SC Dermatologia Pavia Pavia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06879964 on ClinicalTrials.gov ↗ ← All trials in Italy