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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosis of high-grade cutaneous squamous cell carcinoma

patients eligible for post-operative radiotherapy

minimum follow-up of 24 months

Disqualifiers

lack of clinical of histological data

impossibility of a proper follow-up

occurrence of intermediate events (i.e., pregnancy)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 1 trial group
Group A: patients with high-grade cutaneous squamous cell carcinoma

Trial outcomes

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.

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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