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

June 27, 2013 updated by: Papworth Hospital NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Basildon, England, United Kingdom, SS16 5NL
        • Basildon University Hospital
      • Cambridge, England, United Kingdom, CB3 8RE
        • Papworth Hospital
      • Leicester, England, United Kingdom, LE3 9QP
        • Glenfield Hospital
      • London, England, United Kingdom, SE1 9RT
        • Guy's Hospital
      • Sheffield, England, United Kingdom, S1O 2JF
        • Royal Hallamshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival at 1 year after treatment
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: 1 year
1 year
Control of pleural effusion
Time Frame: 1 year
1 year
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
1 year
Symptoms and quality of life as assessed by the EuroQol questionnaire
Time Frame: 0, 1, 3, 6 12 months
0, 1, 3, 6 12 months
Exercise tolerance
Time Frame: 0, 1, 3, 6 12 months
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
Time Frame: 0, 1, 3, 6 12 months
0, 1, 3, 6 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papworth Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Robert Winter, MD, Papworth Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

June 28, 2013

Last Update Submitted That Met QC Criteria

June 27, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P00804
  • PAPWORTH-MESOVATS
  • PAPWORTH-P00804
  • EU-20901
  • ISRCTN34321019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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