DAHANCA 33: Functional Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Loco-regional failure
研究概览
简要总结
Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET scanning
详细描述
Prospective phase II study aiming to improve the outcome in hypoxic resistent patients identified by FAZA-PET.
Inclusion:
Patients must fulfill the following:
Positive hypoxic FAZA-PET Scanning (as described in DAHANCA 24 - see citation) Stage III-IV, Squamous cell carcinoma of the larynx, pharynx or oral cavity (HPVneg (oropharynx) Indication for hyperfractionated accelerated radiotherapy with concommitant cis-platin and nimorazole
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
- •Stage III-IV larynx, pharynx, oral cavity
- •Hypoxic FAZA-PET positive
- •Indication for primary radio-chemotherapy
- •Informed consent
排除标准
- •HPV positive oropharynx cancer
- •Primary surgery
结局指标
主要结局
Loco-regional failure
时间窗: Year 3
loco-regional failure defined as persistent or recurrent disease in tumor and/or regional lymphnode sites (within the radiotherapy treated volume). The primary endpoint did not include the effect of a successful procedure with salvage surgery (no primary neck dissection was allowed).
次要结局
- Acute radiation related morbidity(Month 3)
- Overall survival(Year 3)
- Late radiation related morbidity(Year 3)
- Disease-specific death(Year 3)
研究者
Jens Overgaard
Professor, MD DMSc
Danish Head and Neck Cancer Group