Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck: a Multicenter, Two-arm, Randomized Phase II Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reduction of acute and late treatment-induced dysphagia
研究概览
简要总结
Severe acute and late dysphagia is now considered as a dose-limiting toxicity of radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of life. We propose to preserve swallowing function by:
- adapting (individualizing) treatment (intensity-modulated radiotherapy: IMRT) to per-treatment changes occurring in the tumor and surrounding organs and tissues;
- reducing the volumes of elective neck, that may result in significant decrease of severe acute and late dysphagia.
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 the oral cavity, oropharynx, hypopharynx and larynx.
- •Primary non-resected tumor and/or patients refused surgery
- •Stage T1-4, N0-3; for cancer of the glottis T3-4 or T any N1-3
- •Decision of curative radiotherapy or radiochemotherapy made by a Multidisciplinary Group of Head and Neck Tumors at UZ Gent and UZ Gasthuisberg Leuven
- •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
- •Surgery of the primary tumor except lymph node dissection prior to radiotherapy
- •induction chemotherapy
- •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 at least 5 years
- •Distant metastases
- •Creatinine clearance (Cockroft-Gault) =< 60 milliliter/minute before treatment or creatinine value > 1,3 milligram/deciliter
- •Known allergy to the CT-contrast agents
- •Pregnant or lactating women
- •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
standard radiotherapy treatment
These patients receive the normal standard treatment.
干预措施: video fluoroscopy (Procedure)
standard radiotherapy treatment
These patients receive the normal standard treatment.
干预措施: scoring acute toxicity (Other)
standard radiotherapy treatment
These patients receive the normal standard treatment.
干预措施: scoring of late toxicity (Other)
standard radiotherapy treatment
These patients receive the normal standard treatment.
干预措施: scoring quality of life (QOL) (Other)
adaptive radiotherapy
These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
干预措施: video fluoroscopy (Procedure)
adaptive radiotherapy
These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
干预措施: extra imaging (Procedure)
adaptive radiotherapy
These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
干预措施: scoring acute toxicity (Other)
adaptive radiotherapy
These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
干预措施: scoring of late toxicity (Other)
adaptive radiotherapy
These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
干预措施: scoring quality of life (QOL) (Other)
结局指标
主要结局
Reduction of acute and late treatment-induced dysphagia
时间窗: after 1 year
Reduction of the rates of acute and late treatment-induced dysphagia with experimental treatment as compared to standard treatment.
次要结局
- acute treatment-induced toxicity(weekly during treatment)
- local, regional and distant control: imaging(after 3 months)
- local, regional and distant control: biopsy(from 3 months on)
- local, regional and distant control: clinical examination(after 1,3, 6, 9 and 12 months)
- late treatment-induced toxicity(after 1, 3, 6, 9 and 12 months)
- tumor response: imaging(after 3 months)
- tumor response: clinical examination(after 1, 3, 6, 9 and 12 months)