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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00821860
Other study ID # P00804
Secondary ID PAPWORTH-MESOVAT
Status Completed
Phase Phase 3
First received January 13, 2009
Last updated June 27, 2013
Start date September 2003
Est. completion date May 2013

Study information

Verified date June 2013
Source Papworth Hospital NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


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 / eligibility

Status Completed
Enrollment 196
Est. completion date May 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
talc
Talc pleurodesis
Procedure:
therapeutic thoracoscopy
Talc pleurodesis via thoracoscopy
therapeutic videothoracoscopy
Video-assisted thoracoscopic pleurectomy

Locations

Country Name City State
United Kingdom Basildon University Hospital Basildon England
United Kingdom Papworth Hospital Cambridge England
United Kingdom Glenfield Hospital Leicester England
United Kingdom Guy's Hospital London England
United Kingdom Royal Hallamshire Hospital Sheffield England

Sponsors (1)

Lead Sponsor Collaborator
Papworth Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival at 1 year after treatment 1 year No
Secondary Control of pleural effusion 1 year No
Secondary Complications, including need for more surgery, persistent air leak requiring pleural intubation for > 10 days, and hospital stay for > 12 days 1 year No
Secondary Symptoms and quality of life as assessed by the EuroQol questionnaire 0, 1, 3, 6 12 months No
Secondary Length of hospital stay 1 year No
Secondary Exercise tolerance 0, 1, 3, 6 12 months No
Secondary 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 0, 1, 3, 6 12 months No
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