A Phase I Study of ZD1839 (Iressa) and Hypofractionated Thoracic Radiotherapy With Stereotactic Body Frame Immobilization for Patients With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Patients Affected by Treatment-related Morbidities
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of Iressa when used with a short course of high dose radiation therapy in patients with lung cancer.
详细描述
To estimate treatment-related esophageal, pulmonary, hematologic, and other toxicity of patients with non-small-cell lung cancer (NSCLC) receiving ZD1839 with hypofractionated thoracic radiotherapy (RT). All estimates of toxicity rates will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used due to the two-stage sampling; the method of Conover will be used for tumor response.
To estimate tumor response rates of this treatment regimen and identify the most effective RT dose level, defined as the level associated with the best response rate. Estimates of tumor response rates will be presented with corresponding confidence intervals using the exact method of Conover. Survival will be estimated by the Kaplan-Meier method.
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
- •Histologically confirmed non small cell lung cancer
- •Stage IV needing radiation therapy to control symptoms
- •Patients with brain metastases
- •Unresectable or medically inoperable
排除标准
- •Small cell lung cancer
- •Previous thoracic radiation therapy
- •Oxygen-dependent patients
- •Forced expiratory volume in 1 second (FEV1) less than 1.5
- •Patients with active interstitial lung disease
- •Patients with underlying lung disease
研究组 & 干预措施
Iressa and RT
Iressa plus thoracic RT at the following dose levels:
- Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
- Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
- Level 3: 63.0 Gy in 15 fractions of 4.2 Gy
干预措施: ZD1839 (Iressa) (Drug)
Iressa and RT
Iressa plus thoracic RT at the following dose levels:
- Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
- Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
- Level 3: 63.0 Gy in 15 fractions of 4.2 Gy
干预措施: Thoracic Radiotherapy (Radiation)
结局指标
主要结局
Patients Affected by Treatment-related Morbidities
时间窗: Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy
See "Adverse Events" section for specific toxicities
次要结局
- Progression-free Survival(Baseline to date of progression)
- Survival From Starting Gefitinib(Baseline to date of expiration)
- Tumor Response(Baseline, 1, 3, and 5 months post-treatment)