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.
|First Received Date||January 13, 2009|
|Last Changed Date||June 27, 2013|
|Start Date||September 2003|
|Actual Primary Completion Date||February 2013|
|Primary Outcome Measures||
Survival at 1 year after treatment [Time Frame: 1 year]
|Secondary Outcome Measures||
Control of pleural effusion [Time Frame: 1 year]
Complications, including need for more surgery, persistent air leak requiring pleural intubation for > 10 days, and hospital stay for > 12 days [Time Frame: 1 year]
Symptoms and quality of life as assessed by the EuroQol questionnaire [Time Frame: 0, 1, 3, 6 12 months]
Length of hospital stay [Time Frame: 1 year]
Exercise tolerance [Time Frame: 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 [Time Frame: 0, 1, 3, 6 12 months]
|Study Arms / Comparison Groups||2 / 0|
- 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.
- 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.
OUTLINE: This is a multicenter study. Patients are stratified according to risk (high vs low). Patients are randomized to 1 of 2 treatment arms.
- Arm I (video-assisted thoracoscopic [VAT] cytoreductive pleurectomy): Patients undergo VAT cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.
- Arm II (talc pleurodesis): 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.
Quality of life, complications, and resource use are assessed at baseline and at 1, 3, 6, and 12 months.
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
- Confirmed or suspected mesothelioma
- Any subtype allowed
- Pleural effusion must be present
- 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
|Sponsor||Papworth Hospital NHS Foundation Trust|
|Verification Date||June 2013|