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

Not yet recruiting

• Conditions: Squamous Cell Carcinoma of the Skin

• Registration Number: NCT05246228
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-25
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-15
• Last Update Submitted: 2022-02-15
• Study First Posted: 2022-02-18
• Last Update Posted: 2022-02-18
• Study Start: 2022-03-01
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
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	Evaluation of changes (Δ) in the circulating immune-cells population before the start of radiotherapy and 28 days after the end of radiotherapy.; Correlation between DFS and circulating immune cell population