Immune System Modulation and Outcome in High-risk cSCC Treated With Surgery and Radiotherapy (HR-cSCC)

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status: Not yet enrolling

Conditions: Squamous Cell Carcinoma of the Skin

Treatments: Other: Peripheral blood sampling in order to evaluate changes in the circulating immune population

Study type: Observational

Funder types: Other

Identifiers

NCT05246228

ASST Spedali Civili di Brescia

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 T4.
  • 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).

• Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2.

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.

Trial design

42 participants in 1 patient group

Patient with cSCC addressed to adjuvant radiotherapy as per clinical practice

Description:

The aim of the study is to evaluate patient's outcome according to the post-radiation lymphocytes count and to the changes induced in the immune cell population by a loco-regional treatment as radiotherapy. The way to objectivate these results is to collect some blood samples and analyze them.

Treatment:

Other: Peripheral blood sampling in order to evaluate changes in the circulating immune population