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

NCT ID: NCT06879964

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-17

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cutaneous Squamous Cell Carcinoma (CSCC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with high-grade cutaneous squamous cell carcinoma

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Chiara Giorgini

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione IRCCS Policlinico San Matteo, SC Dermatologia

Pavia, Pavia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Chiara Giorgini, MD

Role: CONTACT

+390382503498

Facility Contacts

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Chiara Giorgini, MD

Role: primary

+390382503498

Other Identifiers

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PORTSCC

Identifier Type: -

Identifier Source: org_study_id

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