Plain English Summary
Trial website
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
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