Condition category
Cancer
Date applied
12/02/2004
Date assigned
16/03/2004
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Vikki Hughes

ORCID ID

Contact details

Papworth Hospital
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
+44 (0)148 036 4821
victoria.hughes@papworth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00821860

Protocol/serial number

2.0

Study information

Scientific title

Prospective randomised controlled trial of video assisted cytoreductive pleurectomy compared to talc pleurodesis in patients with suspected or proven mesothelioma

Acronym

MesoVATS

Study hypothesis

The MesoVATS trial is a randomised phase III study comparing surgical pleurectomy and palliative pleurodesis to determine which is the better at preventing fluid recurrence.

On 15/02/2011 the overall trial end date was changed from 31/12/2009 to 30/06/2012.
On 25/01/2012 the overall trial end date was changed from 30/06/2012 to 30/12/2012.

Ethics approval

Ethics approval received from the local medical ethics committee (LREC) (ref: H02/809)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Mesothelioma

Intervention

Group 1 - pleurodesis:
A procedure in which a chest tube is placed between the lungs and chest wall, and fluid is drained from the intrapleural space. A talc substance will then be administered through the tube. The chest tube will most likely stay in place for a few days following this procedure, and patients will remain hospitalised for about a week.

Group 2 - Video-Assisted Thoracoscopic (VATS) pleurectomy:
A chest tube will be inserted between the lungs and chest wall, and fluid will be drained. Surgery will then be performed to remove the pleural membrane. This is done under general anesthetic, and the chest tube will remain in place for up to 10 days. Patients will remain hospitalised for up to two weeks.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Survival at 1 year
2. Control of effusion
3. Quality of life

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/2003

Overall trial end date

30/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Proven or suspected mesothelioma
2. Pleural tumour with associated pleural effusion
3. Fit enough for Video-Assisted Thoracoscopic (VATS) pleurectomy
4. Patients who have had a previous malignancy for which they are no longer receiving treatment, provided they have a confirmed diagnosis of mesothelioma

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

196

Participant exclusion criteria

1. Patients who are unfit for a VATS procedure
2. Patients who have had previous attempted pleurodesis
3. Patients without a pleural effusion

Recruitment start date

01/09/2003

Recruitment end date

06/01/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Papworth Hospital
Cambridge
CB23 3RE
United Kingdom

Sponsor information

Organisation

Papworth Hospital NHS Foundation Trust (UK)

Sponsor details

Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Sponsor type

Government

Website

http://www.papworthpeople.com/

Funders

Funder type

Industry

Funder name

British United Provident Association (BUPA) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes