Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 9
- 主要终点
- locoregional recurrence-free survival
研究概览
简要总结
This Phase III trial aims to:
Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.
The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area.
To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •biopsy-confirmed squamous cell carcinoma of the oropharynx, oral cavity or hypopharynx
- •stage III/IV, T3-4, Nx M0
- •< 70 yrs
- •glomerular filtration rate (GFR) >60
- •no previous malignancies except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
- •adequate bone marrow function, adequate hepatic function,informed consent
- •>18 years
排除标准
- •expected failure from follow-up
- •previous malignancies except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
- •expected inability to complete either one of the treatment arms
- •pregnancy or lactation
- •patients (m/f) with reproductive potential not implementing adequate contraceptive measures
- •prior surgery, radiotherapy or chemotherapy for this tumor
- •contraindications or serious concomitant diseases preventing the safe administration of chemotherapy and/or radiotherapy or are likely to interfere with the study assessments
- •known active symptomatic fungal, bacterial and/or viral infections including HIV
- •concomitant (or with 4 weeks before randomisation) administration of any other experimental drug
- •concurrent treatment with any other anti-cancer therapy
- •prior treatment with one or more of the active compounds
研究组 & 干预措施
Cisplatinum + adaptive high dose RT
Cisplatinum, 100 mg/m2 on days 1, 22 and 43 with adaptive high dose RT to 84 Gy max on 50% uptake GTV in 7 weeks
干预措施: Adaptive radiotherapy (Radiation)
Cisplatinum + conventional RT
Cisplatinum 100mg/m2 on days 1, 22 and 43, with conventional RT 70 Gy in 7 weeks
干预措施: cisplatinum (Drug)
Cisplatinum + conventional RT
Cisplatinum 100mg/m2 on days 1, 22 and 43, with conventional RT 70 Gy in 7 weeks
干预措施: Conventional radiotherapy (Radiation)
Cisplatinum + adaptive high dose RT
Cisplatinum, 100 mg/m2 on days 1, 22 and 43 with adaptive high dose RT to 84 Gy max on 50% uptake GTV in 7 weeks
干预措施: cisplatinum (Drug)
结局指标
主要结局
locoregional recurrence-free survival
时间窗: 2 years
number of patients with grade 3 toxicity or more
时间窗: 2 years
次要结局
- swallowing preservation(1 year)
- progression free survival(2 years)
- overall survival(2 years)
- Quality of Life assessment(2 years)