A Randomized Phase II Study of Preoperative Versus Postoperative Gemcitabine and Cisplatin for Patients With Stage IB-II Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Time to recurrence
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving chemotherapy before surgery is more effective than giving it after surgery in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying gemcitabine and cisplatin to compare how well they work when given before or after surgery in treating patients with stage I or stage II non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare the time to recurrence in patients with stage IB or II non-small cell lung cancer treated with neoadjuvant versus adjuvant gemcitabine hydrochloride and cisplatin.
Secondary
- Compare overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare quality of life of these patients.
- Compare the complete resection rate with and without neoadjuvant gemcitabine hydrochloride and cisplatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time to recurrence
次要结局
- Overall survival
- Toxicity
- Safety, in terms of frequency, severity, and relationship of adverse events, as assessed by NCI CTCAE v3.0
- Complete resection rate
- Quality of life as assessed by EORTC QLQ-C30 and EORTC QLQ-LC13 at baseline and periodically for 5 years
- Patient population most at risk for disease recurrence