NCT00075699已完成3 期
A Randomized Controlled Trial of Active Symptom Control With or Without Chemotherapy in the Treatment of Patients With Malignant Pleural Mesothelioma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 840
- 试验地点
- 3
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Active symptom control may decrease chest pain, breathlessness, sweating, and general discomfort in patients with malignant pleural mesothelioma. It is not yet known if active symptom control is more effective with or without chemotherapy.
PURPOSE: This randomized phase III trial is studying active symptom control and chemotherapy to see how well they work compared to active symptom control alone in treating patients with malignant pleural mesothelioma.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival of patients with malignant pleural mesothelioma treated with active symptom control (ASC) alone vs ASC and mitomycin, vinblastine, and cisplatin vs ASC and vinorelbine.
Secondary
- Compare the toxic effects of these regimens in these patients.
- Compare symptom palliation (chest pain, breathlessness, malaise, and sweating attacks) in patients treated with these regimens.
- Compare the performance status of patients treated with these regimens.
- Compare analgesic usage in patients treated with these regimens.
- Compare the tumor response and progression-free survival of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
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 and immunohistochemically confirmed malignant pleural mesothelioma
- •Epithelial and other histological types are allowed
- •No more than 3 months since diagnosis
- •Symptomatic pleural effusion must have been treated and brought under control by drainage, pleurodesis, or pleurectomy
- •Prior surgical resection of mesothelioma allowed provided 2 CT scans at least 6 weeks apart show stable or progressive disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC > 3,000/mm^3
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Not specified
- •Creatinine clearance > 50 mL/min
- •See Disease Characteristics
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Considered medically fit to receive chemotherapy
- •No other disease or prior malignancy likely to interfere with protocol treatments or comparisons
- •No clinical evidence of infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for mesothelioma
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Prior local radiotherapy to a wound site after exploratory thoracotomy allowed
- •See Disease Characteristics
- •See Radiotherapy
排除标准
- 未提供
结局指标
主要结局
Overall survival
次要结局
- Palliation of chest pain, breathlessness, malaise (e.g., feeling weak, tiredness, anorexia), and sweating attacks
- Toxicity as measured by the NCIC CTC
- Tumor response as measured by the RECIST criteria
- Performance status as measured by WHO grade
- Analgesic usage
- Quality of life as assessed by the European Organization for Research and Treatment of Cancer
- Progression-free survival as measured by CT scan
研究者
研究点 (3)
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