Clinical trial NCT05246228: Immune System Modulation and Outcome in High-risk cSCC Treated With Surgery and Radiotherapy
Official title: Immune System Modulation and Outcome in High-risk Cutaneous Squamous Cell Carcinoma Treated With Surgery and Radiotherapy: a Prospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Squamous Cell Carcinoma of the Skin
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Azienda Ospedaliera di Padova
name: Istituti Ospitalieri di Cremona
name: IRCCS Sacro Cuore Don Calabria di Negrar
name: ASST Bergamo Ovest
name: San Gerardo Hospital
name: ASST Valcamonica
First posted: 2022-02-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients enrolled in the study are affected form cSCC classified at high risk and addressed to surgery and subsequent adjuvant radiotherapy according to clinical practice.

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.


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.

Primary outcomes:
measure: Disease-free survival (DFS) of patients with ALC < 500 cells/mL 28 days after the end of radiotherapy treatment
timeFrame: 28 days after the end of radiotherapy treatment
Secondary outcomes:
measure: Evaluation of changes (Δ) in the circulating immune-cells population before the start of radiotherapy and 28 days after the end of radiotherapy
timeFrame: Before and 28 days after the end of radiotherapy treatment
Other outcomes:
Locations:
Study officials:
affiliation: ASST Spedali Civili
name: Paolo Bossi, MD
role: PRINCIPAL_INVESTIGATOR
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