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

Study Overview
=================
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.

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

Conditions
-----------------
Malignant Mesothelioma, Metastatic Cancer

Intervention / Treatment
-----------------
* Other: talc
* Procedure: therapeutic thoracoscopy
* Procedure: therapeutic videothoracoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results. | Procedure: therapeutic videothoracoscopy<br>* Video-assisted thoracoscopic pleurectomy<br>|
| Active Comparator: Arm II<br>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. | Other: talc<br>* Talc pleurodesis<br>Procedure: therapeutic thoracoscopy<br>* Talc pleurodesis via thoracoscopy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at 1 year after treatment |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epithelial mesothelioma, recurrent malignant mesothelioma, sarcomatous mesothelioma, malignant pleural effusion, stage IA malignant mesothelioma, stage IB malignant mesothelioma, stage II malignant mesothelioma, stage III malignant mesothelioma, stage IV malignant mesothelioma