A Phase II Study of Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.)
研究概览
简要总结
Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.
详细描述
Patients with non-resectable Non-small Cell Lung Cancer will receive thoracic radiation therapy 60-70 Gy over 30-35 fractions and concurrent with Erlotinib 150mg/day. Followed by Erlotinib 150 mg/day consolidation treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)
- •Tumor EGFR mutation
- •Presence of measurable disease by RECIST
- •stage IIIA or IIIB, non-resectable
- •ECOG performance status 0-2
- •No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
- •Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.
排除标准
- •Carcinoid tumor, small cell carcinoma of lung
- •Patients with any distant metastasis
- •History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- •Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
- •Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women
- •Women and men of childbearing potential who have no willing of employing adequate contraception
- •Tumor EGFR wild
研究组 & 干预措施
Concomitant Erlotinib and radiotherapy
Patients received Erlotinib and radiation therapy.
干预措施: Erlotinib (Drug)
Concomitant Erlotinib and radiotherapy
Patients received Erlotinib and radiation therapy.
干预措施: Thoracic radiotherapy (Radiation)
结局指标
主要结局
Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.)
时间窗: After the thoracic radiotherapy and concurrent Erlotinib treatment
The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)
时间窗: Every one month
次要结局
- Progression free survival(The time from the start of treatment to diease progression)
- The overall survival(The time from the start of treatment to death)
- Quality of Life (QoL was evaluated according to the FACT-L.)(Every one month)