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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Malignant Mesothelioma Metastatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.

Group Type EXPERIMENTAL

therapeutic videothoracoscopy

Intervention Type PROCEDURE

Video-assisted thoracoscopic pleurectomy

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.

Group Type ACTIVE_COMPARATOR

talc

Intervention Type OTHER

Talc pleurodesis

therapeutic thoracoscopy

Intervention Type PROCEDURE

Talc pleurodesis via thoracoscopy

Interventions

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talc

Talc pleurodesis

Intervention Type OTHER

therapeutic thoracoscopy

Talc pleurodesis via thoracoscopy

Intervention Type PROCEDURE

therapeutic videothoracoscopy

Video-assisted thoracoscopic pleurectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No