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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Cutaneous Squamous Cell Carcinoma (CSCC)

Study type: Observational

Funder types: Other

Identifiers

NCT06879964

PORTSCC

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

120 participants in 1 patient group

patients with high-grade cutaneous squamous cell carcinoma