Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma (MesoVATS)
|ClinicalTrials.gov Identifier: NCT00821860|
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : June 28, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma Metastatic Cancer||Other: talc Procedure: therapeutic thoracoscopy Procedure: therapeutic videothoracoscopy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomised Controlled Trial of Video-Assisted Thoracoscopic (VAT) Cytoreductive Pleurectomy Compared to Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||May 2013|
Experimental: Arm I
Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.
Procedure: therapeutic videothoracoscopy
Video-assisted thoracoscopic pleurectomy
Active Comparator: 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.
Procedure: therapeutic thoracoscopy
Talc pleurodesis via thoracoscopy
- Survival at 1 year after treatment [ Time Frame: 1 year ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821860
|Basildon University Hospital|
|Basildon, England, United Kingdom, SS16 5NL|
|Cambridge, England, United Kingdom, CB3 8RE|
|Leicester, England, United Kingdom, LE3 9QP|
|London, England, United Kingdom, SE1 9RT|
|Royal Hallamshire Hospital|
|Sheffield, England, United Kingdom, S1O 2JF|
|Principal Investigator:||Robert Winter, MD||Papworth Hospital|