Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Effusion control
研究概览
简要总结
RATIONALE: It is not yet known whether pleurodesis using a chest tube with infusions of talc is more effective in improving quality of life than pleurodesis using a small catheter in treating malignant pleural effusion.
PURPOSE: Randomized phase III trial to compare the effectiveness of a chest tube and talc with that of a small catheter in treating malignant pleural effusion in patients who have cancer.
详细描述
OBJECTIVES:
- Compare the success rate in patients with cancer who undergo pleurodesis using a standard chest tube with talc slurry vs a small (PleurX) catheter for the treatment of a symptomatic unilateral malignant pleural effusion.
- Compare the 30-day effusion control rate in patients treated with these procedures.
- Compare quality of life in these patients at 7-14 and 30-37 days after treatment with these procedures.
- Compare patient acceptance and satisfaction after treatment with these procedures.
- Compare the level of symptoms and dyspnea experienced by patients treated with these procedures.
- Compare the types, causes, and rates of early technical failures of these procedures in these patients.
- Compare the 30-day effusion recurrences in patients treated with these procedures.
- Compare the 60-day durability of pleurodesis in patients treated with these procedures.
- Compare the mortality, morbidity, and common surgical complications in patients treated with these procedures.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to inpatient status (yes vs no), disease type (breast vs lung vs other), and concurrent systemic chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo placement of a standard pleural chest tube. Within 36 hours of chest tube placement, patients undergo pleurodesis comprising intrapleural administration of talc slurry once followed by clamping of the chest tube for 2 hours while different patient positions are used to distribute the talc. The chest tube is then unclamped to allow continuous drainage. When the chest tube drainage is less than 150 mL over 24 hours, pleurodesis is assumed and the chest tube is removed.
- Arm II: Patients undergo pleurodesis comprising placement of a small (PleurX) catheter followed by pleural drainage for up to 90 minutes once daily. When the catheter drainage is less than 30 mL per day for 3 consecutive days, pleurodesis is assumed and the catheter is removed.
Quality of life and dyspnea are assessed at baseline and then at 7-14 and 30-37 days after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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:
- •Radiologic evidence of a unilateral malignant pleural effusion requiring sclerosis or ongoing drainage because it is symptomatic (dyspnea and/or progressive fatigue)
- •An asymptomatic patient is eligible if the patient underwent a prior thoracentesis within the past 2 weeks and was symptomatic before the procedure
- •No bilateral effusions by plain chest x-ray
- •Histologically or cytologically confirmed solid tumor or hematologic malignancy
- •Histologic confirmation of malignant cells in pleural fluid is not required
- •Pleural spaces must be naive to pleurodesis attempts
- •No prior intrapleural therapy (defined as a chest tube in place or placed to drain an effusion, prior surgical pleurectomy, or any prior chemical or mechanical pleurodesis on the ipsilateral side)
- •Placement of a small interventional radiology catheter for temporary drainage is not considered intrapleural therapy as long as no sclerosant medication was given and it has not been in place longer than 10 days
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Hematopoietic
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No active pleural infection
- •No allergy to talc
- •No surgical contraindication to talc usage
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Chemotherapy
- •Concurrent systemic chemotherapy allowed
- •Radiotherapy
- •Concurrent palliative radiotherapy to a symptomatic lesion allowed except to the treated hemithorax within 30 days of the drainage procedure
- •See Disease Characteristics
- •Prior thoracotomies without specific pleural ablation (including lobectomy but not pneumonectomy) allowed
- •Prior needle-based diagnostic interventions (fine-needle aspiration, small bore catheter drainage of less than 10 days, or thoracentesis) allowed
排除标准
- 未提供
研究组 & 干预措施
Arm II
Patients undergo pleurodesis comprising placement of a small (PleurX) catheter followed by pleural drainage for up to 90 minutes once daily. When the catheter drainage is less than 30 mL per day for 3 consecutive days, pleurodesis is assumed and the catheter is removed.
干预措施: dyspnea management (Procedure)
Arm I
Patients undergo placement of a standard pleural chest tube. Within 36 hours of chest tube placement, patients undergo pleurodesis comprising intrapleural administration of talc slurry once followed by clamping of the chest tube for 2 hours while different patient positions are used to distribute the talc. The chest tube is then unclamped to allow continuous drainage. When the chest tube drainage is less than 150 mL over 24 hours, pleurodesis is assumed and the chest tube is removed.
干预措施: talc (Other)
结局指标
主要结局
Effusion control
时间窗: 30 days
次要结局
- Quality of Life(7-14 days and 30-37 days)