NCT00616785Unknown2 期
Phase II Trial Irinotecan and Cisplatin Induction Chemotherapy Followed by Radiotherapy Concurrently With Etoposide/Cisplatin in Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Rate of local/regional control
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan, cisplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To evaluate the efficacy of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in patients with locally advanced, unresectable stage III non-small cell lung cancer.
- To evaluate the feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy after induction chemotherapy in these patients.
Secondary
- To evaluate the toxicity of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in these patients.
- To assess whether this induction chemotherapy regimen will improve patient survival when compared with outcomes from the predecessor study, SWOG-9019.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- •Stage IIIA (N2) or IIIB disease
- •Pathologic documentation of N2-3 mediastinal lymph nodes is encouraged but not required if nodal size is ≥ 1.5 cm in largest diameter
- •No stage IIIB disease with malignant pleural effusion or superior sulcus tumor
- •At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors
- •Unresectable disease
- •No known brain metastasis
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy > 3 months
- •ANC ≥ 1,500/mm³
- •Hemoglobin ≥ 9.0 g/dL (can be corrected by transfusion)
- •Platelet count ≥ 100,000/mm³
- •Creatinine < 1.5 mg/dL
- •Total bilirubin < 2 times upper limit of normal (ULN)
- •Transaminases < 3 times ULN
- •Patient compliance and geographic proximity that allow adequate follow up
- •No serious, uncontrolled systemic intercurrent illness (e.g., infections or poorly controlled diabetes)
- •No history of significant neurological or mental disorder, including seizures or dementia
- •No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
- •No active cardiac disease not controlled by therapy
- •No myocardial infarction within the past 12 months
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy or radiotherapy for NSCLC
- •No other concurrent systemic chemotherapy, investigational drug, or radiotherapy
排除标准
- 未提供
结局指标
主要结局
Rate of local/regional control
Rate of systemic disease control
Feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy
次要结局
- Toxicity of irinotecan hydrochloride and cisplatin induction chemotherapy as assessed by NCI CTCAE v3.0
- Progression-free survival
- Overall survival
研究者
研究点 (2)
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