NCT00398385Unknown2 期
A Randomized Phase II Study of Preoperative Versus Postoperative Gemcitabine and Cisplatin for Patients With Stage IB-II Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 170
- 试验地点
- 1
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- •Squamous cell or nonsquamous cell histology
- •Stage IB or II disease
- •Tumor amenable to curative surgical resection
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- •Medical fitness must be adequate for radical NSCLC surgery
- •WBC ≥ 4,000/mm³
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 10 g/dL
- •Bilirubin normal
- •ALT and AST ≤ 2.5 times upper limit of normal
- •Creatinine ≤ 1.5 mg/dL
- •No second primary malignancy
- •No active uncontrolled infection
- •No concurrent serious disorder that would compromise patient safety or tolerance of study therapy
- •No significant neurological or mental disorder
- •No myocardial infarction within the past 6 months
- •No symptomatic heart disease, including any of the following:
- •Unstable angina
- •Congestive heart failure
- •Uncontrolled arrhythmia
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy or anticancer therapy
- •No prior surgery for NSCLC
- •No prior or concurrent radiotherapy or immunotherapy (e.g., biologic response modifier)
- •No major surgery (other than biopsy) within the past 2 weeks
- •No other concurrent anticancer therapy
- •No other concurrent investigational agents
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
研究者
研究点 (1)
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