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| ID | Type | Description | Link |
|---|---|---|---|
| PAPWORTH-MESOVATS | |||
| PAPWORTH-P00804 | |||
| EU-20901 | |||
| ISRCTN34321019 |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to risk (high vs low). Patients are randomized to 1 of 2 treatment arms.
Quality of life, complications, and resource use are assessed at baseline and at 1, 3, 6, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results. |
|
| Arm II | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| talc | Other | Talc pleurodesis |
| |
| therapeutic thoracoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 1 year after treatment | 1 year |
| 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 | |
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DISEASE CHARACTERISTICS:
Confirmed or suspected mesothelioma
Pleural effusion must be present
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Winter, MD | Papworth Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basildon University Hospital | Basildon | England | SS16 5NL | United Kingdom | ||
| Papworth Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24942631 | Derived | Rintoul RC, Ritchie AJ, Edwards JG, Waller DA, Coonar AS, Bennett M, Lovato E, Hughes V, Fox-Rushby JA, Sharples LD; MesoVATS Collaborators. Efficacy and cost of video-assisted thoracoscopic partial pleurectomy versus talc pleurodesis in patients with malignant pleural mesothelioma (MesoVATS): an open-label, randomised, controlled trial. Lancet. 2014 Sep 20;384(9948):1118-27. doi: 10.1016/S0140-6736(14)60418-9. Epub 2014 Jun 16. |
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| Procedure |
Talc pleurodesis via thoracoscopy |
|
| therapeutic videothoracoscopy | Procedure | Video-assisted thoracoscopic pleurectomy |
|
| 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 |
| Cambridge |
| England |
| CB3 8RE |
| United Kingdom |
| Glenfield Hospital | Leicester | England | LE3 9QP | United Kingdom |
| Guy's Hospital | London | England | SE1 9RT | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | England | S1O 2JF | United Kingdom |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| D009362 | Neoplasm Metastasis |
| D054363 | Solitary Fibrous Tumor, Pleural |
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054364 | Solitary Fibrous Tumors |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
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| ID | Term |
|---|---|
| D013627 | Talc |
| ID | Term |
|---|---|
| D017633 | Magnesium Silicates |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D017640 | Silicates |
| D008903 | Minerals |
| D012824 | Silicic Acid |
| D012822 | Silicon Dioxide |
| D017655 | Silicon Compounds |
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