Mapping of Sentinel Lymph Node Drainage Using SPECT to Tailor Highly-Selective Elective Nodal Irradiation in Node-Negative Neck of Patients With Head and Neck Cancer (SUSPECT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Feasibility and safety of single side radiation therapy measured by physical examination and toxicity measurement by CTCAE 4.03 at 12 weeks
研究概览
简要总结
This study aims to explore the feasibility, safety and outcome of a non-invasive sentinel node mapping (SNM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only and to exclude the contralateral negative neck from the irradiation fields when there is no draining sentinel node. Subsequently the dose to the salivary glands, mucosal area and the swallowing and chewing muscles and structures involved in voicing and articulation will significantly be reduced
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with histopathologic proven primary HNSCC (T1 -3 N0 -1) located in the oral cavity, oropharynx, larynx (except T1 glottic ), and hypopharynx, not crossing the midline and planned for treatment with (chemo)radiotherapy in curative setting
- •No chemotherapy or surgery prior to inclusion
- •No distant metastatic spread at the time of inclusion
- •Age ≥ 18 years
- •WHO performance status 0 or 1
- •Signed written informed consent
排除标准
- •Patients with previously radiation treatment in the head and neck region, for any reason
- •Patients with previous neck dissection
- •Patients with recurrent or second primary tumor in the head and neck region
- •Patients with head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus
- •Previous history of cancer in the last five years (excluding basal cell carcinoma of the skin and in situ SCC of the cervix)
- •Pregnancy or no active contraception for pre-menopausal women
- •Known hypersensitivity to iodine or nanocolloid injection
- •Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow up schedules
研究组 & 干预措施
Squamous Head and Neck Cancer
radiation
干预措施: radiation in Squamous Head and Neck Cancer (Radiation)
结局指标
主要结局
Feasibility and safety of single side radiation therapy measured by physical examination and toxicity measurement by CTCAE 4.03 at 12 weeks
时间窗: 12 weeks
mapping of sentinel lymph node drainage to indentify groups at low risk of the probability of contra regionale failure is to be estimated to be 2% at 2 years. A recurrrence rate of \>15% will be assumed unacceptable
次要结局
未报告次要终点