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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00821860
First received: January 13, 2009
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Malignant Mesothelioma
Metastatic Cancer
Other: talc
Procedure: therapeutic thoracoscopy
Procedure: therapeutic videothoracoscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Papworth Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Survival at 1 year after treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Control of pleural effusion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Symptoms and quality of life as assessed by the EuroQol questionnaire [ Time Frame: 0, 1, 3, 6 12 months ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Exercise tolerance [ Time Frame: 0, 1, 3, 6 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 196
Study Start Date: September 2003
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821860

Locations
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
Principal Investigator: Robert Winter, MD Papworth Hospital
  More Information

Additional Information:
No publications provided

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
Study First Received: January 13, 2009
Last Updated: June 27, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on September 22, 2014