A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- To test success rate of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-guided radiotherapy (intensity-modulated radiotherapy (IMRT) and/or helical tomotherapy).
研究概览
简要总结
Adaptive dose painting appears to increase the chance of cure at minimized radiation-induced toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also be of importance in IMRT for recurrent and second primary head and neck cancers in previously irradiated territory.
This trial investigates the feasibility of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography-voxel ([18F]FDG-PET-voxel) intensity-based IMRT in reirradiation of patients with recurrent and second primary 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 recurrences and second primary squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx in the previously irradiated territory.
- •Primary unresectable tumor and/or patients refused surgery.
- •No grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy for primary head and neck cancer.
- •Minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer.
- •Decision of a multidisciplinary tumor board on curative radiotherapy (in combination or not with targeted therapy with cetuximab)
- •Karnofsky performance status ≥70%.
- •Age ≥ 18 years old.
- •Informed consent obtained, signed and dated before specific protocol procedures.
排除标准
- •Previous radiotherapy for cT1-2 cN0 M0 glottic cancer.
- •Brachytherapy as treatment for second primary / recurrence.
- •Distant metastases.
- •Other second primary tumors that are not under control.
- •Pregnant or lactating women.
- •Elevated blood creatinine level.
- •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.
研究组 & 干预措施
Reirradiation of recurrent and 2nd primary head/neck cancer.
干预措施: [18F]FDG-PET-voxel intensity-based IMRT (Radiation)
结局指标
主要结局
To test success rate of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-guided radiotherapy (intensity-modulated radiotherapy (IMRT) and/or helical tomotherapy).
时间窗: 2 year
To test feasibility of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography (\[18F\]FDG-PET)-guided radiotherapy (intensity-modulated radiotherapy (IMRT) and/or helical tomotherapy) in treatment of recurrent and second primary head and neck cancer in the previously irradiated territory.
次要结局
- Estimation time to progression.(At 6, 9 and 12 months)
- Evaluation tumor response.(After 3 months.)
- Number of Participants with Adverse Events.(Up to 3 months.)