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

NCT06879964 | Recruiting

• 1 other identifier: PORTSCC
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

Outcome Measures

Primary Outcomes (1)

• effectiveness of post-operative radiotherapy in preventing local and regional recurrences

  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.

  24 months

Study Arms (1)

patients with high-grade cutaneous squamous cell carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with a diagnosis of high-grade cutaneous squamous cell carcinoma, eligible for post-operative radiotherapy, cared for at the Dermatologic Clinic, Fondazione IRCCS Policlinico San Matteo.

You may qualify if:

• diagnosis of high-grade cutaneous squamous cell carcinoma
• patients eligible for post-operative radiotherapy
• minimum follow-up of 24 months

You may not qualify if:

• lack of clinical of histological data
• impossibility of a proper follow-up
• occurrence of intermediate events (i.e., pregnancy)

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo, SC Dermatologia

Pavia, Pavia, 27100, Italy

RECRUITING

Central Study Contacts

Chiara Giorgini, MD

CONTACT

+390382503498; c.giorgini@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: November 17, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 17, 2025

Record last verified: 2025-02

Locations

IT (1)