Mapping of Sentinel Lymph Node Drainage Using SPECT/CT to Tailor Highly Selective Elective Nodal Irradiation in Node-negative Neck of Patients With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Contralateral regional failure
研究概览
简要总结
This study aims to explore the safety and outcome of lymph drainage mapping(LDM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only. The goal is to exclude the contralateral negative neck from the irradiation fields when there is no contralateral draining sentinel node. In case contralateral lymph drainage is found on SPECT/CT, a contralateral sentinel node procedure (SNP) is performed to remove the draining node. The patient will only receive contralateral ENI if (micro/macro)metastasis are found in this contralateral sentinel node.
详细描述
The SUSPECT2 study is a modified concept from the first SUSPECT study (N14SUS). The first study investigated whether lymph drainage mapping (LDM) using SPECT/CT was a safe and feasible method to exclude the contralateral neck from irradiation, or, in case of contralateral lymph drainage, to tailor the contralateral ENI field to the level containing the tracer accumulation. In this study, large dose reductions to most organs at risk were realized, as well as significant reductions of both short term (mucositis, dysphagia) and long term (xerostomia, dysphagia) toxicities.
Firstly, the SUSPECT2 study aims to expand the inclusion criteria of the original SUSPECT study. Secondly, it aims to further reduce the proportion of patients that undergoes bilateral ENI, by performing a contralateral sentinel node procedure (SNP) in case of contralateral lymph drainage. The patient will only receive contralateral ENI if (micro/macro)metastasis are found in this contralateral sentinel node.
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 and histopathologically proven primary HNSCC
- •T1-4N0-2b
- •Tumor does not cross midline
- •WHO performance status 0 or 1
- •Signed written informed consent
排除标准
- •Distant metastatic spread at the time of inclusion
- •Chemotherapy or surgery (for the present tumor), prior to inclusion
- •Previous radiation treatment in the head and neck region, for any reason
- •Previous neck dissection
- •Recurrent or second primary tumor in the head and neck region
- •Head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus
- •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
Unilateral elective nodal irradiation
Exclusion of contralateral neck from elective nodal irradiation, based on results of SPECT/CT and (in case of contralateral drainage) contralateral sentinel node procedure.
干预措施: Unilateral elective nodal irradiation (Radiation)
结局指标
主要结局
Contralateral regional failure
时间窗: 1 year
Cumulative incidence of contralateral regional metastasis.
次要结局
- Health-related quality of life(Until 18 months after end of radiotherapy)
- Treatment toxicity(Until 2 years after end of radiotherapy)