Prospective Randomised Controlled Trial of Video-Assisted Thoracoscopic (VAT) Cytoreductive Pleurectomy Compared to Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 5
- 主要终点
- Survival at 1 year after treatment
研究概览
简要总结
RATIONALE: Video-assisted surgery to remove part of the tissue layer covering the inside of the chest cavity may be effective in treating pleural effusion and cause less damage to normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is not yet known which therapy is more effective in treating pleural effusion caused by malignant mesothelioma.
PURPOSE: This randomized phase III trial is studying video-assisted surgery to see how well it works compared with talc pleurodesis in treating patients with malignant mesothelioma.
详细描述
OBJECTIVES:
Primary
- Compare the effectiveness of video-assisted thoracoscopic cytoreductive pleurectomy vs talc pleurodesis, in terms of 1-year survival, in patients with suspected or proven malignant mesothelioma.
Secondary
- Compare the control of pleural effusion in these patients.
- Compare procedure-related complications in these patients.
- Compare the symptoms and quality of life of these patients at 3, 6, and 12 months after treatment.
- Compare the length of hospital stay for these patients.
- Compare the exercise tolerance of these patients at 3, 6, and 12 months after treatment.
- Determine the cost to the health service, in terms of resources used for procedures, hospital bed usage, and cost of primary and secondary care over 12 months.
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:
- •Confirmed or suspected mesothelioma
- •Any subtype allowed
- •Pleural effusion must be present
- •PATIENT CHARACTERISTICS:
- •Clinically fit and suitable for video-assisted thoracoscopic cytoreductive pleurectomy
- •Prior malignancy allowed provided it no longer requires treatment AND patient has a confirmed diagnosis of mesothelioma
- •PRIOR CONCURRENT THERAPY:
- •No prior attempted pleurodesis by any approach
排除标准
- 未提供
研究组 & 干预措施
Arm II
Patients undergo talc pleurodesis via an indwelling intercostal chest drain or via thoracoscopy either at the time of biopsy or after confirmation of biopsy results.
干预措施: therapeutic thoracoscopy (Procedure)
Arm I
Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.
干预措施: therapeutic videothoracoscopy (Procedure)
Arm II
Patients undergo talc pleurodesis via an indwelling intercostal chest drain or via thoracoscopy either at the time of biopsy or after confirmation of biopsy results.
干预措施: talc (Other)
结局指标
主要结局
Survival at 1 year after treatment
时间窗: 1 year
次要结局
- Control of pleural effusion(1 year)
- Complications, including need for more surgery, persistent air leak requiring pleural intubation for > 10 days, and hospital stay for > 12 days(1 year)
- Symptoms and quality of life as assessed by the EuroQol questionnaire(0, 1, 3, 6 12 months)
- Length of hospital stay(1 year)
- Exercise tolerance(0, 1, 3, 6 12 months)
- Cost to the health service, in terms of resources used for procedures, hospital bed usage, and cost of primary and secondary care over 12 months(0, 1, 3, 6 12 months)