NCT00821860

Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma

Prospective Randomised Controlled Trial of Video-Assisted Thoracoscopic (VAT) Cytoreductive Pleurectomy Compared to Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Papworth Hospital NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Mesothelioma
• Metastatic Cancer

Interventions

Type	Name	Description
OTHER	talc	Talc pleurodesis
PROCEDURE	therapeutic thoracoscopy	Talc pleurodesis via thoracoscopy
PROCEDURE	therapeutic videothoracoscopy	Video-assisted thoracoscopic pleurectomy

Timeline

• Start date: 2003-09-01
• Primary completion: 2013-02-01
• Completion: 2013-05-01
• First posted: 2009-01-14
• Last updated: 2013-06-28

Locations

5 sites across 1 country: United Kingdom