NCT00886678Unknown2 期
A Phase II Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- tumor response rate
研究概览
简要总结
Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).
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 70 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 (non-squamous cell carcinoma)
- •Presence of measurable disease by RECIST
- •Inoperable stage IIIA or IIIB
- •ECOG performance status 0-1
- •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 within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity or situation with contraindication for chemotherapy (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 14 days before the first administration) and pregnant women
- •Women and men of childbearing potential who have no willing of employing adequate contraception
研究组 & 干预措施
1
Experimental
patients receiving pemetrexed, carboplatin and radiation therapy.
干预措施: pemetrexed (Drug)
1
Experimental
patients receiving pemetrexed, carboplatin and radiation therapy.
干预措施: carboplatin (Drug)
1
Experimental
patients receiving pemetrexed, carboplatin and radiation therapy.
干预措施: thoracic radiation (Radiation)
结局指标
主要结局
tumor response rate
时间窗: Tumor assessments after completion of chemoradiotherapy and every 2 months
次要结局
- the safety profile(every cycle)
- site of first failure in patients who develop progressive disease(baseline to measured progressive disease)
- overall survival(baseline to date of death from any cause)
- time to progressive disease(baseline to measured progressive disease)
研究者
研究点 (1)
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