Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Local Control Rate
研究概览
简要总结
This study will evaluate the local control rates as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck tumors.
详细描述
This single site, non-randomized, prospective, phase IV study includes 3 patient groups to be treated with SBRT:
- Benign tumors, such as paraganglioma, chordoma, chondrosarcoma, as the sole treatment or to gross residual disease after maximal safe resection
- Malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, after initial external beam radiation (Residual Disease Group)
- Unresectable malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, adenocarcinomas, and sarcomas which are recurrent after prior radiation (Primary RT Group) Data collected will include baseline patient demographics, pathology data, radiation therapy procedure, tumor recurrence data, and toxicities.
Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age > 18 years
- •Zubrod performance status of 0-3
- •Benign head and neck tumors such as paragangliomas, chordoma, chondrosarcoma
- •Malignant head and neck cancers such as invasive squamous cell carcinoma, adenocarcinoma, nasopharyngeal carcinoma, salivary gland cancers, and sarcoma
- •Signed study-specific consent form
排除标准
- •Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
- •Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
研究组 & 干预措施
Benign Tumors
Benign head and neck tumors will be treated with SBRT
干预措施: stereotactic body radiotherapy (Radiation)
Malignant Tumors
Malignant Head and Neck Tumors will be treated with SBRT.
干预措施: Stereotactic body radiotherapy (Radiation)
结局指标
主要结局
Local Control Rate
时间窗: 5 years
Complete or partial tumor response or stable disease
Local Recurrence
时间窗: 5 years
Instances of progressive disease
Complication Rate
时间窗: 5 years
Number of participants with any adverse event
次要结局
- Overall Survival(5 years)