NCT00030810已完成2 期
Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Rate of event-free survival measured 1 year after registration
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the feasibility and efficacy of sequential neoadjuvant docetaxel, cisplatin, and radiotherapy followed by surgery in patients with operable stage IIIB non-small cell lung cancer.
- Determine the rate of event-free survival at 1 year in patients treated with this regimen.
- Determine the operability and complete resection rate in patients treated with this regimen.
- Determine the postoperative 30-day mortality in patients treated with this regimen.
- Determine the response rate, failure pattern, and overall survival in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity.
Beginning 3 weeks after the last chemotherapy dose, patients without progressive disease receive radiotherapy 1-2 times daily on days 1-5, 8-12, and 15-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed, operable stage IIIB non-small cell lung cancer
- •T4 N0-3 M0 or T1-4 N3 M0 by bronchoscopy and mediastinoscopy (required for assessment of N3 disease) or CT scan or MRI of the thorax
- •Squamous cell
- •Adenosquamous cell
- •Large cell
- •Poorly differentiated
- •No prior or concurrent metastatic disease by CT scan or MRI of the brain, bone scan, and abdominal ultrasound or CT scan
- •No malignant pleural or pericardial effusion
- •No invasion of the aorta, esophagus, myocardium, or supraclavicular nodes
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •AST and/or ALT no greater than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No unstable cardiac disease requiring treatment
- •No congestive heart failure
- •No angina pectoris (even if medically controlled)
- •No significant arrhythmia
- •No myocardial infarction within the past 3 months
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No definite contraindications for the use of corticosteroids as premedication
- •No preexisting grade 2 or greater peripheral neuropathy
- •No active uncontrolled infection
- •No uncontrolled diabetes mellitus
- •No other prior or concurrent malignancy except non-melanomatous skin cancer or adequately treated carcinoma in situ of the cervix
- •No prior significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude informed consent
- •No other serious underlying medical condition that would preclude study participation
- •No socioeconomic or geographical circumstances that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •No concurrent corticosteroids except as prophylactic pretreatment medication, treatment for acute hypersensitivity reactions, or chronic treatment (initiated more than 6 months ago) at low-dose (no more than 20 mg methylprednisolone or equivalent)
- •Radiotherapy:
- •No prior radiotherapy to the chest
- •See Disease Characteristics
- •At least 30 days since prior treatment in a clinical trial
- •No prior cytostatic therapy
- •No other concurrent experimental drugs
排除标准
- 未提供
结局指标
主要结局
Rate of event-free survival measured 1 year after registration
次要结局
- Toxicity
- Complete resection rate after surgery
- Response rate
- Operability after chemotherapy
- Postoperative mortality 30 days after surgery
研究者
研究点 (2)
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