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NCT Number: NCT06879964

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

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.

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Key information

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo, SC Dermatologia

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Chiara Giorgini, MD

CONTACT

[email protected]

+390382503498

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Giorgini, MD

CONTACT

[email protected]

+390382503498

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Acronym: PORTSCC

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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