Evaluating the impact of post-operative radiotherapy on high-grade skin cancer
Usefulness of Post-Operative Radiotherapy in High-grade Cutaneous Squamous Cell Carcinoma: an Observational Study
This study is testing if getting radiation therapy after surgery helps people with high-grade skin cancer live longer and have fewer recurrences compared to those who don't get the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT06879964 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of post-operative radiotherapy (PORT) in patients with high-grade cutaneous squamous cell carcinoma (CSCC). It compares two cohorts: one that receives PORT and another that opts out despite its necessity. The study will evaluate the impact of PORT on recurrence rates and overall survival over a minimum follow-up period of 24 months. The findings could provide valuable insights into the role of PORT in managing this aggressive skin cancer.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with high-grade cutaneous squamous cell carcinoma who are eligible for post-operative radiotherapy.
Not a fit: Patients who lack sufficient clinical or histological data or cannot undergo proper follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help establish post-operative radiotherapy as a standard treatment to reduce recurrence rates in high-grade CSCC patients.
How similar studies have performed: While few studies have explored the impact of PORT on recurrence rates, this study aims to fill a gap by providing a controlled comparison, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Pavia, Pavia
- Fondazione IRCCS Policlinico San Matteo, SC Dermatologia — Pavia, Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Chiara Giorgini, MD
- Email: c.giorgini@smatteo.pv.it
- Phone: +390382503498
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.