NCT00389688终止2 期
Randomized Phase II Study of Pemetrexed and Cisplatin as Either Induction or Adjuvant Chemotherapy in Stage IB-II Non-Small Cell Lung Cancer (NSCLC)
European Organisation for Research and Treatment of Cancer - EORTC2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2006年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Successful treatment delivery
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium 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 more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective before or after surgery in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying the side effects of pemetrexed disodium and cisplatin and comparing how well they work when given before or after surgery in treating patients with stage IB or stage II non-small cell lung cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare the tolerability (in terms of drug delivery and toxicity) of neoadjuvant vs adjuvant chemotherapy comprising cisplatin and pemetrexed disodium in patients with resectable stage IB or II non-small cell lung cancer.
Secondary
- Determine the overall toxicity of this regimen in these patients.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the overall clinical response rate, pathologic complete response, and resectability rate in patients treated with neoadjuvant chemotherapy.
- Determine the surgical morbidity and mortality of patients treated with these regimens.
- Determine the fraction of patients in the adjuvant arm that receives chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Pathologically confirmed non-small cell lung cancer (NSCLC)
- •Stage IB or II disease
- •Resectable disease
- •At least 1 measurable lesion
- •No mediastinal involvement by mediastinoscopy and/or positron emission tomography with fludeoxyglucose F 18 scan
- •No evidence of metastatic disease
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Absolute neutrophil count > 1,500/mm³
- •Platelet count > 100,000/mm³
- •Hemoglobin > 10 g/dL
- •Creatinine clearance ≥ 60 mL/min
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 3.0 times ULN
- •AST and ALT ≤ 3.0 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignant disease, except for the following:
- •Basocellular carcinoma of the skin
- •Adequately treated carcinoma in situ of the cervix
- •Low-grade prostate cancer
- •Other cancer for which the patient has been disease-free for ≥ 5 years
- •No congestive heart failure or angina pectoris unless medically controlled
- •No myocardial infarction within the past 6 months
- •No uncontrolled hypertension or arrhythmia
- •No active uncontrolled infection requiring antibiotics
- •No illness or medical condition that would preclude study participation
- •No pre-existing motor or sensory neurotoxicity ≥ grade 2
- •PRIOR CONCURRENT THERAPY:
- •No prior surgery for NSCLC
- •No prior or other concurrent chemotherapy for NSCLC
- •No prior or concurrent radiotherapy for NSCLC
- •No concurrent immunotherapy
- •No concurrent targeted agents
- •No concurrent hormonal cancer therapy
- •No concurrent routine colony-stimulating factor (e.g., prophylactic filgrastim [G-CSF])
- •No aspirin or nonsteroidal anti-inflammatory drugs within 5 days before or after chemotherapy
- •No other concurrent experimental treatments
- •No other concurrent anticancer treatments
排除标准
- 未提供
结局指标
主要结局
Successful treatment delivery
Toxicity (no grade 4) during chemotherapy
次要结局
- Overall toxicity (all grades)
- Progression-free survival and overall survival
- Overall clinical response rate (neoadjuvant chemotherapy arm)
- Pathologic complete response (neoadjuvant chemotherapy arm)
- Resectability rate (neoadjuvant chemotherapy arm)
- Surgical morbidity and mortality
- Fraction of patients that actually receives chemotherapy (adjuvant chemotherapy arm)
研究者
研究点 (2)
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