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

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ClinicalTrials.gov Identifier: NCT00821860
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : June 28, 2013
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

Study Description
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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.


Condition or disease Intervention/treatment Phase
Malignant Mesothelioma Metastatic Cancer Other: talc Procedure: therapeutic thoracoscopy Procedure: therapeutic videothoracoscopy Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arms and Interventions
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Arm Intervention/treatment
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.
 Other: talc
Talc pleurodesis

Procedure: therapeutic thoracoscopy
Talc pleurodesis via thoracoscopy


Outcome Measures
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Primary Outcome Measures :
  1. Survival at 1 year after treatment [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Control of pleural effusion [ Time Frame: 1 year ]
  2. 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 ]
  3. Symptoms and quality of life as assessed by the EuroQol questionnaire [ Time Frame: 0, 1, 3, 6 12 months ]
  4. Length of hospital stay [ Time Frame: 1 year ]
  5. Exercise tolerance [ Time Frame: 0, 1, 3, 6 12 months ]
  6. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821860


Locations
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United Kingdom
Basildon University Hospital
Basildon, England, United Kingdom, SS16 5NL
Papworth Hospital
Cambridge, England, United Kingdom, CB3 8RE
Glenfield Hospital
Leicester, England, United Kingdom, LE3 9QP
Guy's Hospital
London, England, United Kingdom, SE1 9RT
Royal Hallamshire Hospital
Sheffield, England, United Kingdom, S1O 2JF
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Robert Winter, MD Papworth Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00821860     History of Changes
Other Study ID Numbers: P00804
PAPWORTH-MESOVATS
PAPWORTH-P00804
EU-20901
ISRCTN34321019
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013

Keywords provided by Papworth Hospital NHS Foundation Trust:
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

Additional relevant MeSH terms:
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Mesothelioma
Neoplasm Metastasis
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
 Neoplastic Processes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases