Immune System Modulation and Outcome in High-risk Cutaneous Squamous Cell Carcinoma Treated With Surgery and Radiotherapy: a Prospective Study

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia0 sites42 target enrollmentMarch 1, 2022

ConditionsSquamous Cell Carcinoma of the Skin

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Squamous Cell Carcinoma of the Skin
Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Enrollment: 42
Primary Endpoint: Disease-free survival (DFS) of patients with ALC < 500 cells/mL 28 days after the end of radiotherapy treatment
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Treatment with adjuvant radiotherapy modulates immune system in many diseases as witnessed by dynamic changes of humoral and cellular immunity. Moreover, the persistent lymphopenia after radiation therapy is a negative prognostic factor. This study is aimed to explore the changes in immune-cell populations during radiotherapy given as adjuvant treatment for high-risk cutaneous squamous cell carcinomas and to correlate them with patient's outcome.

Registry

clinicaltrials.gov

Start Date

March 1, 2022

End Date

December 30, 2025

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Responsible Party

Principal Investigator

Paolo Bossi

Clinical Professor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years.
•Signed written informed consent.
•Histologically confirmed diagnosis of cSCC.
•cSCC categorized as high risk according to ASTRO Guidelines:
•close or positive margins that cannot be corrected with further surgery (secondary to morbidity or adverse cosmetic outcome).
•gross perineural spread, as identified by radiological or pathological assessment.
•disease recurrence after a prior margin-negative resection.
•pathological stage T3 and T
•desmoplastic or infiltrative tumors in the setting of chronic immunosuppression at pathological exam, cSCC involving regional lymphnodes, with the exception of a single, small (\<3 cm) cervical lymph node harboring carcinoma, without extracapsular extension.
•cSCC addressed to adjuvant radiotherapy as per clinical practice (a complete post-operative treatment should be administered with 50-54 or 60-66 Gy depending on the margin status).

Exclusion Criteria

•cSCC not eligible for surgery.
•cSCC not eligible for adjuvant radiotherapy for any condition depending on disease characteristics or patient characteristics, co-morbidities or refusal.
•Any concurrent investigational product, biologic, or hormonal therapy for cancer treatment.
•Concurrent treatment with chemotherapy for the purpose of cSCC cure.
•History or current evidence of any condition that, in the opinion of the treating investigator, might interfere with the subject's participation for the full duration of the trial.
•Any major surgery, different from that planned for the protocol, in the 15 days before the protocol starting.
•Any radiotherapy treatment in the 28 days before the protocol starting
•Pregnant or breastfeeding.

Outcomes

Primary Outcomes

Disease-free survival (DFS) of patients with ALC < 500 cells/mL 28 days after the end of radiotherapy treatment

Time Frame: 28 days after the end of radiotherapy treatment

Disease-free survival (DFS) of patients with ALC \< 500 cells/mL 28 days after the end of radiotherapy treatment

Secondary Outcomes

Evaluation of changes (Δ) in the circulating immune-cells population before the start of radiotherapy and 28 days after the end of radiotherapy(Before and 28 days after the end of radiotherapy treatment)