A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multicentre Comparative Study of Gefitinib 250 mg or 500 mg (IRESSA™) Given Either Continuously or Concomitantly With Cisplatin Plus Radiotherapy for the Treatment of Patients With Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Local Disease Control Rate at 2 Years
研究概览
简要总结
The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 or cytologically confirmed stage III or IVA squamous cell carcinoma of the head and neck
- •No prior surgery or chemotherapy/biological therapy/radiation therapy
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- •Life expectancy of more than 12 weeks
排除标准
- •Cancers of the nasal space, oral cavity and larynx; or certain lung diseases.
- •Abnormal blood chemistry; uncontrolled respiratory, cardiac, hepatic, or renal disease; or coexisting malignancies.
研究组 & 干预措施
1
Radiation + cisplatin; followed by placebo as maintenance therapy
干预措施: cisplatin (Drug)
7
placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
干预措施: radiotherapy (Radiation)
1
Radiation + cisplatin; followed by placebo as maintenance therapy
干预措施: radiotherapy (Radiation)
2
250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
干预措施: Gefitinib (Iressa) (Drug)
2
250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
干预措施: cisplatin (Drug)
2
250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
干预措施: radiotherapy (Radiation)
3
500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
干预措施: cisplatin (Drug)
3
500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
干预措施: radiotherapy (Radiation)
3
500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
干预措施: Gefitinib (Iressa) (Drug)
4
gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
干预措施: Gefitinib (Iressa) (Drug)
4
gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
干预措施: cisplatin (Drug)
4
gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
干预措施: radiotherapy (Radiation)
5
gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
干预措施: cisplatin (Drug)
5
gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
干预措施: radiotherapy (Radiation)
5
gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
干预措施: Gefitinib (Iressa) (Drug)
6
placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
干预措施: Gefitinib (Iressa) (Drug)
6
placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
干预措施: cisplatin (Drug)
6
placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
干预措施: radiotherapy (Radiation)
7
placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
干预措施: cisplatin (Drug)
7
placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
干预措施: Gefitinib (Iressa) (Drug)
结局指标
主要结局
Local Disease Control Rate at 2 Years
时间窗: Assessed at 2 yrs. Tumour assessments (clinical & by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by Response evaluation criteria in solid tumours (RECIST)).
A patient demonstrated local disease control at 2 years if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.
次要结局
- Local Disease Control Rate at 1 Year(Assessed after 1 year. Tumour assessments (clinical and by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by RECIST).)
- Complete Response(Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression.)
- Tumour Response (Complete Response + Partial Response)(Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression)
- Progression Free Survival(Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression (as defined by RECIST))
- Overall Survival(Overall survival assessed at 2 years)
- Safety and Tolerability(Assessed over two years)