Randomized Phase II Study for Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinomas Treated With Radiochemotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- time to local recurrence
研究概览
简要总结
Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a hypoxia scan either by magnetic resonance tomography, computed tomography or fluoromisonidazole (FMISO)-PET-CT. Patients presenting with hypoxia are randomized into standard therapy consisting of intensity modulated radiotherapy (IMRT) with 70 Gy plus either 5-fluorouracil/mitomycin C or cisplatinum (Arm A) or a dose escalation of 10% (77Gy) to the hypoxic volume applied via simultaneous integrated boost in addition to the standard treatment (Arm B).
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 verified squamous cell carcinoma of the head and neck region stage III and IV eligible for primary radiochemotherapy
- •measurabel disease by CT and/or MRT and/or FDG-PET-CT
- •fit for chemotherapy
- •no prior radiotherapy or major surgery in the head/neck region
- •Karnofsky Index > 60%
- •informed consent
排除标准
- •uncontrolled secondary cancer
- •distant metastases
- •pregnancy
- •expected malcompliance
研究组 & 干预措施
Standard therapy
Standard radiochemotherapy (70 Gy, 5-fluorouracil 600 mg/m2 d1-5, mitomycin C d1+36 or cisplatinum 40 mg/m2 weekly for 5 weeks)
干预措施: radiochemotherapy with 70 Gy (Radiation)
dose escalation
Standard plus 10% dose escalation to the hypoxic volume
干预措施: radiochemotherapy with 77 Gy (Radiation)
结局指标
主要结局
time to local recurrence
时间窗: 5 years
次要结局
未报告次要终点