Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma
- Conditions
- Malignant MesotheliomaMetastatic Cancer
- Interventions
- Procedure: therapeutic videothoracoscopyOther: talcProcedure: therapeutic thoracoscopy
- Registration Number
- NCT00821860
- Lead Sponsor
- Papworth Hospital NHS Foundation Trust
- Brief Summary
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.
- Detailed Description
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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 196
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I therapeutic videothoracoscopy Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results. Arm II talc 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. Arm II therapeutic thoracoscopy 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.
- Primary Outcome Measures
Name Time Method Survival at 1 year after treatment 1 year
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (5)
Royal Hallamshire Hospital
🇬🇧Sheffield, England, United Kingdom
Papworth Hospital
🇬🇧Cambridge, England, United Kingdom
Basildon University Hospital
🇬🇧Basildon, England, United Kingdom
Glenfield Hospital
🇬🇧Leicester, England, United Kingdom
Guy's Hospital
🇬🇧London, England, United Kingdom