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

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.

Tracking Information
First Received DateJanuary 13, 2009
Last Changed DateJune 27, 2013
Start DateSeptember 2003
Actual Primary Completion DateFebruary 2013
Primary Outcome Measures

Survival at 1 year after treatment [Time Frame: 1 year]

Secondary Outcome Measures

Control of pleural effusion [Time Frame: 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]

Symptoms and quality of life as assessed by the EuroQol questionnaire [Time Frame: 0, 1, 3, 6 12 months]

Length of hospital stay [Time Frame: 1 year]

Exercise tolerance [Time Frame: 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]

Descriptive Information
PhasePhase 3
Study TypeInterventional
Condition
  • Malignant Mesothelioma
  • Metastatic Cancer
Intervention
  • Other: talc
  • Procedure: therapeutic thoracoscopy
  • Procedure: therapeutic videothoracoscopy
Study Arms / Comparison Groups2 / 0
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.

Recruitment Information
Recruitment StatusCompleted
Actual Enrollment196
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility 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

Administrative Information
NCTIDNCT00821860
Responsible Party,
SponsorPapworth Hospital NHS Foundation Trust
Verification DateJune 2013
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