DAHANCA 19: A Randomized Study of the Importance of the EGFr-Inhibitor Zalutumumab for the Outcome After Primary Curative Radiotherapy for Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 619
- 试验地点
- 1
- 主要终点
- Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab
研究概览
简要总结
The purpose of this study is to determine whether the addition of the fully human EGFr antibody zalutumumab to primary curative radiotherapy increases locoregional control in Squamous Cell Carcinomas of the Head and Neck.
详细描述
Radiotherapy to Squamous Cell Carcinomas of the Head and Neck have been modified during the last decades by altered fractionation, the addition of concomitant chemotherapy or modification of hypoxia. By these modifications the locoregional control, disease-specific survival or overall survival have been increased but the price have been increased morbidity.
The addition of antibodies against the Epidermal Growth Factor receptor (EGFR-I) may further increase the control and survival of patients with Squamous Cell Carcinomas of the Head and Neck when combined with radiotherapy and/or chemotherapy.
The aim of the present study is to determine whether
- The addition af the EGFr-I zalutumumab increases locoregional control in Squamous Cell Carcinomas of the Head and Neck
- Whether disease-specific survival or overall survival is improved by addition of zalutumumab
- Whether the addition of zalutumumab to primary curative radiotherapy or chemoradiotherapy is feasible and tolerable
- Acute and late toxicity to the treatment.
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
- •Histological proven squamous cell carcinoma of the pharynx, larynx (excp. stage 1 larynx and stage 1+2 glottic larynx)
- •Curative intent and no prior treatment
- •Age > 18 years
- •WHO performance 0-2 (incl.)
- •No prior treatment with EGFr-I
- •Informed consent according to local guidelines and national law
- •The patient is able (psychological, sociological, geographical and physical) to carry through the treatment and follow-up
- •Fertile women must use contraceptive devices (IUD or oral contraceptives)
排除标准
- •Rhinopharynx or carcinomas of unknown origin
- •Distal metastases
- •Other malignant diseases (prior or current) except from planocellular skin cancer
研究组 & 干预措施
1
Radiotherapy (+cisplatin to stage 3+4)
干预措施: Radiotherapy (Radiation)
2
Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4) + Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)
干预措施: Zalutumumab (Drug)
结局指标
主要结局
Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab
时间窗: 5 years
次要结局
- Disease-specific survival and overall control Acute and late toxicity(5 years)