NCT05246228尚未招募不适用
Immune System Modulation and Outcome in High-risk Cutaneous Squamous Cell Carcinoma Treated With Surgery and Radiotherapy: a Prospective Study
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia0 个研究点目标入组 42 人开始时间: 2022年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- Disease-free survival (DFS) of patients with ALC < 500 cells/mL 28 days after the end of radiotherapy treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 T
- •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.
排除标准
- •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.
结局指标
主要结局
Disease-free survival (DFS) of patients with ALC < 500 cells/mL 28 days after the end of radiotherapy treatment
时间窗: 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
次要结局
- 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)
研究者
Paolo Bossi
Clinical Professor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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