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

NHS Foundation Trust

Status and phase: Completed; Phase 3

Conditions: Metastatic Cancer; Malignant Mesothelioma

Treatments: Procedure: therapeutic videothoracoscopy; Other: talc; Procedure: therapeutic thoracoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT00821860

P00804

ISRCTN34321019

EU-20901

PAPWORTH-P00804

PAPWORTH-MESOVATS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Arm I

Experimental group

Description:

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

Treatment:

Procedure: therapeutic videothoracoscopy

Arm II

Active Comparator group

Description:

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.

Treatment:

Other: talc

Procedure: therapeutic thoracoscopy