A Two-arm Phase II Randomized Study, Comparing Adaptive Biological Imaging - Voxel Intensity - Based Radiotherapy (Adaptive Dose Escalation) Versus Standard Radiotherapy for Head and Neck Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment.
研究概览
简要总结
The investigators hypothesize that treatment adaptation to biological and anatomical changes, occurring during treatment, can increase the chance of cure at minimized or equal radiation-induced toxicity in head and neck cancer patients. This trial compares standard intensity-modulated radiotherapy (IMRT), using only pre-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography to adaptive 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography voxel intensity based IMRT or volumetric-modulated arc therapy (VMAT) using repetitive per-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography for head and neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 oral cavity, oropharynx, hypopharynx or larynx
- •Primary unresectable tumor and/or patients that refused surgery
- •Stages T1-4; T3-4 N0 or T(any) N1-3 for glottic cancer
- •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
- •High risk Human Papilloma Virus (HPV)
- •Treatment combined with brachytherapy
- •Prior irradiation to the head and neck region
- •History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.
- •Distant metastases
- •Pregnant or lactating women
- •Creatinine clearance (Cockcroft-Gault) =< 60 mL/min
- •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 obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment.
时间窗: at 1 year
18F-FDG-PET/CT scans will be performed.
次要结局
- Topography of local and/or regional relapse.(during the first year post-treatment)
- Time point of local and/or regional relapse.(during the first year post-treatment)
- Acute toxicity(up to 12 months of follow-up)
- Overall disease-specific, disease-free survival.(at 1 year)
- Late toxicity(up to 12 months of follow-up)
- Regional (elective neck) and distant control.(after 1 year)
- Tumor response(3 months post-treatment)