NCT00174837已完成3 期
Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 317
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.
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
- •Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
- •Stage III or IV disease (excluding T1N1, and T2N1 and metastatic disease).
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
- •Absolute neutrophil count at least 1.5 X 10^9/L, platelet count at least 100 X 10^9/L, and hemoglobin > 9g/dL.
- •Serum bilirubin < 1.25 times upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine transaminase (ALT) < 2.5 times ULN.
- •Calculated creatinine clearance (Cockcroft-Gault) > 55 mL/min.
排除标准
- •Metastatic Disease
- •Primary cancers of the nasal and paranasal cavities and of the nasopharynx
- •Significant intercurrent illness that will interfere with the Chemotherapy or Radiation Therapy during the trial
- •Symptomatic peripheral neuropathy > grade 2
- •Clinically significant hearing impairment
- •Significant cardiac disease
研究组 & 干预措施
Tirapazamine + Cisplatin
Experimental
干预措施: Tirapazamine (Drug)
Tirapazamine + Cisplatin
Experimental
干预措施: Cisplatin (Drug)
Cisplatin
Active Comparator
干预措施: Cisplatin (Drug)
结局指标
主要结局
Overall survival
时间窗: Study period
次要结局
- Toxicity and Safety(Study period)
- Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final complete response (CR) Rate at Six Months After Completion of Therapy(Study period)
- Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure(Study period)
- Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy(Study period)
研究者
研究点 (2)
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