Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 11
- 主要终点
- Disease control rate after 3 months of treatment
研究概览
简要总结
Pneumonic adenocarcinoma (P-ADC) is defined as a primary lung ADC with a radiological pneumonic presentation, usually referred to histologically as ADC with a mixed-invasive and BAC predominant subtype in the 2004 WHO classification. Surgery is the best therapy for resectable tumors since the effectiveness of chemotherapy is disappointing. In the advanced P-ADC diffuse/multifocal types of BAC, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) (gefitinib and erlotinib) have shown promise, with some rapid, dramatic responses, possibly reflecting specific molecular differences from other non-small cell lung carcinomas.
详细描述
We therefore conducted a French multicentric phase II trial (IFCT 0401) to evaluate activity and tolerance of gefitinib (250 mg/day) administered as first line treatment in patients with non-resectable P-ADC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Pathologically / cytologically proven ADC-P
- •Non-resectable disease
- •3-month expected survival
- •No prior radiotherapy or chemotherapy
- •Age >= 18 years old
- •Performance status < 4 (WHO)
- •Adequate blood biological parameters
排除标准
- •Abnormal initial fibroscopy
研究组 & 干预措施
1
干预措施: Gefitinib (Drug)
结局指标
主要结局
Disease control rate after 3 months of treatment
时间窗: Month
次要结局
- Quality of life(3-month)
- Time to progression(month)
- Survival(month)
- Prediction disease control by clinical and biological markers(month)