NCT01208883已完成1 期
A FEASIBILITY STUDY ON CONTINUOUS ADAPTIVE [18F]FDG-PET-GUIDED RADIOTHERAPY FOR HEAD AND NECK CANCER
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To assess volume changes of the targets and organs at risk as detected by repetitive per-treatment [18F]FDG-PET/CT.
研究概览
简要总结
Treatment adaptation to biological and anatomical changes occurring during treatment can increase the chance of cure at minimized radiation-induced toxicity in head and neck cancer patients. This trial investigates the feasibility of using repetitive per-treatment [18F]FDG-PET acquired during treatment in adaptive [18F]FDG-PET-voxel intensity-based intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT) for head and neck cancer.
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
- •Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx.
- •Primary unresectable tumor and/or patients refused surgery.
- •Stage T1-4; T3-4 N0 or Tany N1-3 for cancer of the glottis.
- •Multidisciplinary decision of curative radiotherapy or radiochemotherapy.
- •Karnofsky performance status ≥70%.
- •Age ≥ 18 years old.
- •Informed consent obtained, signed and dated before specific protocol procedures.
排除标准
- •Treatment combined with brachytherapy.
- •Prior irradiation to the head and neck region.
- •Distant metastases.
- •Second primary tumors that are not under control
- •Pregnant or lactating women.
- •Creatinine clearance (Cockcroft-Gault) ≤ 60 mL/min before treatment.
- •Allergy to the CT-contrast agents.
- •Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- •Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
结局指标
主要结局
To assess volume changes of the targets and organs at risk as detected by repetitive per-treatment [18F]FDG-PET/CT.
时间窗: at time of per-treatment [18F]FDG-PET/CT
次要结局
未报告次要终点
研究者
研究点 (1)
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