Status:
UNKNOWN
Immune System Modulation and Outcome in High-risk cSCC Treated With Surgery and Radiotherapy
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Collaborating Sponsors:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Azienda Ospedaliera di Padova
Conditions:
Squamous Cell Carcinoma of the Skin
Eligibility:
All Genders
18+ years
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 the...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05246228
Start Date
March 1 2022
End Date
December 30 2025
Last Update
February 18 2022
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