NCT06472570招募中不适用
Escalating a Biological Dose of Radiation in the Target Volume Applying Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours
Maria Sklodowska-Curie National Research Institute of Oncology2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年10月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Response to treatment
研究概览
简要总结
The goal of this study is to evaluate the safety and efficacy of the stereotactic boost applied in patients with H&N tumours.
详细描述
Aims of the study:
- Evaluation of the efficacy of the stereotactic boost applied in patients with head and neck tumours.
- Evaluation of the safety of the stereotactic boost applied in patients with head and neck tumours.
- Evaluation of the influence of the stereotactic radiotherapy boost on blood parameters reflecting tumour response (interleukin 6 (Il-6), thymidine kinase (TK), Fms-related tyrosine kinase 1 (sFlt-1)), and normal tissue response (C-reactive protein (CRP)).
In the case of beneficial findings, the stereotactic radiosurgery boost in the course of radio(chemo)therapy in patients with head and neck tumours will be able to replace traditional techniques of radiation, and radical schemes of treatment will be possible for future development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with squamous cell carcinoma (SCC) or adenoid cystic carcinoma (ACC) of the H&N region qualified for radical treatment with (definitive or adjuvant (adjuvant radiotherapy or radiochemotherapy in postoperative cases of R2 resection or early locoregional recurrence unsuitable for reoperation)) radiotherapy or radiochemotherapy.
- •Patients with other malignant tumours of the H&N region (sarcomas, neuroendocrine carcinomas, differentiated carcinomas, undifferentiated carcinomas, or basaloid carcinomas) qualified for radical treatment with (definitive or adjuvant (adjuvant radiotherapy or radiochemotherapy in postoperative cases of R2 resection or early locoregional recurrence unsuitable for reoperation)) radiotherapy or radiochemotherapy.
- •Patients with nonmalignant tumours of the H&N region (tumour mixtus or paraganglioma) demanding definitive or adjuvant radiotherapy.
- •Age: 18-80 years. Biomedicines 2022, 10, 1484 5 of 12
- •Performance status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Conscious agreement to participate in the clinical trial.
排除标准
- •Do not meet the inclusion criteria.
- •Decompensated diabetes mellitus.
- •Myocardial infarction occurred up to 6 months before.
- •Mental disorder preclusive of making a conscious agreement
结局指标
主要结局
Response to treatment
时间窗: one month after the end of treatment, every 3 months in the first year, every 4 months in the second year, and every six months in the third-fifth years
Response to treatment in imaging tests and clinical examination-local control (LC) and locoregional control (LRC).
次要结局
- Treatment tolerance(an average of 3 months)
- Evaluation of safety Terminology Criteria for Adverse Events (CTCAE)v4.0.(5 years after the end of treatment)
- Evaluation of efficacy(5 years after the end of treatment)
研究者
研究点 (2)
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