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

Metastatic Cancer Clinical Trial

— MesoVATS  

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

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma
• Metastatic Cancer
• Neoplasm Metastasis

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