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

January 13, 2009
June 27, 2013
September 2003
February 2013   (final data collection date for primary outcome measure)
Survival at 1 year after treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Survival at 1 year after treatment [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00821860 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Control of pleural effusion [ 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 [ Designated as safety issue: No ]
  • Symptoms and quality of life as assessed by the EuroQol questionnaire [ Designated as safety issue: No ]
  • Length of hospital stay [ Designated as safety issue: No ]
  • Exercise tolerance [ 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 [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Malignant Mesothelioma
  • Metastatic Cancer
  • Other: talc
    Talc pleurodesis
  • Procedure: therapeutic thoracoscopy
    Talc pleurodesis via thoracoscopy
  • Procedure: therapeutic videothoracoscopy
    Video-assisted thoracoscopic pleurectomy
  • Experimental: Arm I
    Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.
    Intervention: Procedure: therapeutic videothoracoscopy
  • 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.
    Interventions:
    • Other: talc
    • Procedure: therapeutic thoracoscopy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
196
May 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00821860
P00804, PAPWORTH-MESOVATS, PAPWORTH-P00804, EU-20901, ISRCTN34321019
Yes
Papworth Hospital NHS Foundation Trust
Papworth Hospital NHS Foundation Trust
Not Provided
Principal Investigator: Robert Winter, MD Papworth Hospital
Papworth Hospital NHS Foundation Trust
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP