Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole for Patients With Stage III-IV p16 Negative Squamous Cell Cancer (SCC) of the Larynx, Pharynx and Oral Cavity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Compliance
研究概览
简要总结
P16 negative cancers continue to have a dismal prognosis despite advances in the treatment of head and neck cancer. Acceleration, dose-escalation, hyperfractionation, chemotherapy and nimorazole has been shown to improve local control. The purpose of the study i to investigate the level of co-morbidity and performance status (PS) that allows the combination of all of the above means of treatment intensification
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Squamous Cell Carcinoma head and neck cancer of the pharynx, larynx and oral cavity
- •P16 negative
- •Organ function and performance status allowing radical chemo-radiotherapy
排除标准
- 未提供
研究组 & 干预措施
Group A
Performance scale 0-1, Charlson co-morbidity score=0 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
干预措施: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole (Radiation)
Group B
PS 0-1 Charlson=1 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
干预措施: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole (Radiation)
Group C
PS 0-1 Charlson >=2 Will start inclusion after Group A and B Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
干预措施: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole (Radiation)
Group D
PS 2, Charlson: Any Will start inclusion after Group C Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
干预措施: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole (Radiation)
结局指标
主要结局
Compliance
时间窗: End of radiotherapy (approximately 5.5 weeks after start of radiotherapy)
Proportion of patients that receive radiotherapy in accordance to prescribed dose and treatment time
次要结局
- Acute toxicity(2 months after end of radiotherapy)
- Response rate(2 months after end of radiotherapy)