Geweberetraktoren für Die Strahlentherapie Von Kopf-Hals-Tumoren - Prospektive Randomisierte Phase-II-Studie
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Toxcicity
研究概览
简要总结
The rate of therapy-associated side effects during and after radiotherapy of head and neck tumors is essential. The most effective approach to reducing acute toxicity is to cut out healthy tissue from the radiation field. The distance between the tumor and normal tissue can be individually increased using personalized, 3D printer-based tissue retractors (GWR). Even the smallest geometric changes lead to a significant dose reduction in normal tissue and significant advantages for the patient.
The current randomized phase II study evaluates the use of GWR with regard to acute toxicity. In addition, quality of life, long-term toxicity as well as local control and overall survival 12 months after radiotherapy are evaluated.
详细描述
The most effective approach to reducing acute toxicity after radiotherapy is to cut out healthy tissue from the radiation field. GWR can increase the distance between the tumor and normal tissue. Even the smallest geometric changes lead to a significant dose reduction in normal tissue and significant advantages for the patient. Adequate immobilization also reduces unwanted movements, especially of the tongue.
The GWR are manufactured as combinable modules according to the "modular principle". This improves reproducibility and flexibility and reduces development and manufacturing costs. The study is being conducted as a monocentric, prospective, randomized phase II study. A total of 34 patients who meet the inclusion criteria are examined for acute toxicity after radiotherapy of a malignant head and neck tumor. The primary goal of the study is to reduce acute toxicity through individual immobilization of the jaw and tongue. Secondary study goals are the evaluation of quality of life and long-term toxicity as well as local control and overall survival twelve months after radiotherapy. In both groups, radiation therapy is carried out in accordance with guidelines using image-guided radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a malignant head and neck tumor
- •Clinical target volume of radiotherapy may include portions of at least one region: oral cavity; Upper jaw; Lower jaw; Oropharynx; Hypopharynx; large salivary glands
- •Indication for radiotherapy alone (postoperative or definitive)
- •Age ≥ 18 years
- •Karnofsky performance score ≥ 60
- •Completed wound healing after tumor resection
- •The patient's consent and written consent
- •Ability of the patient to assess the nature and scope as well as possible consequences of the clinical study
- •Adequate contraception in women of childbearing potential and in men
排除标准
- •Pre-radiation in the head and neck area
- •Multifocal, diffuse growing tumors
- •Inadequate regression of toxicities from previous therapies
- •Jaw clamp (cutting edge distance ≤ 2 cm)
- •Simultaneous systemic tumor therapy during radiation (especially chemotherapy and immunotherapy)
- •Indications that the participant is unlikely to adhere to the study protocol (e.g. lack of compliance)
- •Missing written declaration of consent
结局指标
主要结局
Toxcicity
时间窗: immediately after completin of Radiotherapy
Number of grade III toxcicity events
次要结局
- Assesment of Quality of life: questionnaire(up to 12 month after completion of radiotherapy)
研究者
Juergen Debus
Head of Department
University Hospital Heidelberg