NCT00259285终止2 期
Alimta (Pemetrexed) and Cisplatin Treatment as Neoadjuvant Therapy in Non Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Treatment Response
研究概览
简要总结
To determine the response to this regimen for therapy prior surgery in patients with locally advanced disease or metastatic disease.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of non-small-cell carcinoma of the lung
- •Patients with locally advanced disease or metastatic disease, candidates to surgery after evaluation by oncologist and thoracic surgeon
- •Tumour with possibility of curative surgery
- •At least one uni-dimensionally measurable lesion
- •Adequate pulmonary function to perform the planned surgical resection
排除标准
- •Active infection (at the investigator's discretion)
- •Pregnancy or breast-feeding
- •Serious concomitant illness at the investigator's discretion
- •Previous diagnosis of malignant disease
- •They have received treatment during the last 30 days with a drug, other than the study drug, that has not received regulatory approval for any indication at the time of their entry in the study
研究组 & 干预措施
A
Experimental
干预措施: pemetrexed (Drug)
A
Experimental
干预措施: cisplatin (Drug)
结局指标
主要结局
Treatment Response
时间窗: every 21 day cycle (3 cycles) and 3-4 weeks after last cycle
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
次要结局
- Pathologic Remissions After Surgery(surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy))
- Relapse-free Survival(Every 21 day cycle (3 cycles) and then every 3 months for the first 2 years, every 6 months until 5 years have elapsed and annually thereafter)
研究者
研究点 (1)
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