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Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: January 13, 2009 Last Updated: June 9, 2009 History of Changes
Sponsored by: Papworth Hospital
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00821860
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 thoracoscopic surgery Procedure: therapeutic thoracoscopy Procedure: therapeutic videothoracoscopy Phase III
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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:
MedlinePlus related topics: Cancer Mesothelioma Surgery
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
  • Survival at 1 year after treatment [ Designated as safety issue: No ]
Secondary Outcome Measures:
  • 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 ]
Estimated Enrollment: 196
Study Start Date: September 2003
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.
Procedure: therapeutic thoracoscopic surgery
Video-assisted thoracoscopic pleurectomy
Procedure: therapeutic videothoracoscopy
Video-assisted thoracoscopic pleurectomy
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821860
Locations
United Kingdom, England
Basildon University Hospital Recruiting
Basildon, England, United Kingdom, SS16 5NL
Contact: Contact Person 44-1268-533-911
Glenfield Hospital Recruiting
Leicester, England, United Kingdom, LE3 9QP
Contact: Contact Person 44-116-287-1471
Guy's Hospital Recruiting
London, England, United Kingdom, SE1 9RT
Contact: Contact Person 44-20-7188-7188
Papworth Hospital Recruiting
Cambridge, England, United Kingdom, CB3 8RE
Contact: Contact Person 44-1480-364-821
Royal Hallamshire Hospital Recruiting
Sheffield, England, United Kingdom, S1O 2JF
Contact: Contact Person 44-114-271-1900
Sponsors and Collaborators
Papworth Hospital
Investigators
Principal Investigator: Robert Winter, MD Papworth Hospital
More Information Additional Information: No publications provided
Study ID Numbers: CDR0000630699, PAPWORTH-MESOVAT, PAPWORTH-P00804, EU-20901, ISRCTN34321019
Study First Received: January 13, 2009
Last Updated: June 9, 2009
ClinicalTrials.gov Identifier: NCT00821860 History of Changes
Health Authority: Unspecified
Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma epithelial mesothelioma localized malignant mesothelioma recurrent malignant mesothelioma sarcomatous mesothelioma malignant pleural effusion
Study placed in the following topic categories:
Pleural Effusion Neoplasm Metastasis Pleural Effusion, Malignant Mesothelioma Adenoma Recurrence Neoplasms, Glandular and Epithelial
Additional relevant MeSH terms:
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Histologic Type Mesothelioma Neoplasms, Mesothelial Neoplasm Metastasis Adenoma Neoplasms, Glandular and Epithelial
ClinicalTrials.gov processed this record on August 10, 2009 Source: http://www.clinicaltrials.gov

Source: http://www.clinicaltrials.gov