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

Launched by AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA · Feb 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system responds to radiation therapy in patients with high-risk squamous cell carcinoma of the skin (cSCC) after surgery. The researchers want to understand how treatment affects immune cells and whether these changes can help predict how well patients will do after their treatment. The trial aims to gather important information that could improve future treatments for this type of skin cancer.

To participate in the trial, you need to be at least 18 years old and have a confirmed diagnosis of high-risk cSCC that meets specific criteria, such as having close surgical margins or signs of tumor spread. You also need to be in good overall health, as determined by a standard performance scale. Participants will receive radiation therapy as part of their treatment plan, and they will be monitored closely throughout the trial. It's important to know that this trial is not yet recruiting participants, so there may be some time before it begins.

Gender

ALL

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 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.