NCT06879964 Usefulness of Post-Operative Radiotherapy in High-grade Cutaneous Squamous Cell Carcinoma: an Observational Study
| NCT ID | NCT06879964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | Cutaneous Squamous Cell Carcinoma (CSCC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-11-17 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2023-11-17 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06879964 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cutaneous Squamous Cell Carcinoma (CSCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06879964 currently recruiting?
Yes, NCT06879964 is actively recruiting participants. Contact the research team at c.giorgini@smatteo.pv.it for enrollment information.
Where is the NCT06879964 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT06879964 clinical trial?
NCT06879964 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The trial plans to enroll 120 participants.