Malignant MesotheliomaPhase 3MesoVATSNCT00821860
Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma
A Phase 3 study testing talc, therapeutic thoracoscopy and therapeutic videothoracoscopy in people with Malignant Mesothelioma and Metastatic Cancer, run by Papworth Hospital NHS Foundation Trust at 5 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Mesothelioma, Metastatic Cancer
- What is being tested?
- talc, therapeutic thoracoscopy and therapeutic videothoracoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Sep 2003to May 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Basildon University Hospital
Basildon, England, SS16 5NL
Papworth Hospital
Cambridge, England, CB3 8RE
Glenfield Hospital
Leicester, England, LE3 9QP
Guy's Hospital
London, England, SE1 9RT
Royal Hallamshire Hospital
Sheffield, England, S1O 2JF
About this study
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
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.
Read the detailed 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.
- Conditions
- Malignant Mesothelioma, Metastatic Cancer
- Being tested
- talc, therapeutic thoracoscopy, therapeutic videothoracoscopy
- Keywords
- epithelial mesothelioma, recurrent malignant mesothelioma, sarcomatous mesothelioma, malignant pleural effusion, stage IA malignant mesothelioma, stage IB malignant mesothelioma, stage II malignant mesothelioma, stage III malignant mesothelioma, stage IV malignant mesothelioma
- Medical subject headings
- Mesothelioma, Malignant, Neoplasm Metastasis, Solitary Fibrous Tumor, Pleural, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talcOther
Talc pleurodesis
therapeutic thoracoscopyProcedure or surgery
Talc pleurodesis via thoracoscopy
therapeutic videothoracoscopyProcedure or surgery
Video-assisted thoracoscopic pleurectomy
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results. Receives: Procedure: therapeutic videothoracoscopy |
| Arm II | Active comparator | 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. Receives: Other: talc; Procedure: therapeutic thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 1 year after treatment
Measured: 1 year
Secondary outcomes (6)
Control of pleural effusion
Measured: 1 year
Complications, including need for more surgery, persistent air leak requiring pleural intubation for > 10 days, and hospital stay for > 12 days
Measured: 1 year
Symptoms and quality of life as assessed by the EuroQol questionnaire
Measured: 0, 1, 3, 6 12 months
Length of hospital stay
Measured: 1 year
Exercise tolerance
Measured: 0, 1, 3, 6 12 months
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
Measured: 0, 1, 3, 6 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startSep 2003
- Primary completionFeb 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Robert Winter, MD, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821860
- Sponsor's protocol ID
- P00804
- Other IDs
- PAPWORTH-MESOVATS, PAPWORTH-P00804, EU-20901, ISRCTN34321019
- Acronym
- MesoVATS
- Status last verified
- Jun 2013
- First submitted
- 13 Jan 2009
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rintoul RC, Ritchie AJ, Edwards JG, Waller DA, Coonar AS, Bennett M, Lovato E, Hughes V, Fox-Rushby JA, Sharples LD; MesoVATS Collaborators. Efficacy and cost of video-assisted thoracoscopic partial pleurectomy versus talc pleurodesis in patients with malignant pleural mesothelioma (MesoVATS): an open-label, randomised, controlled trial. Lancet. 2014 Sep 20;384(9948):1118-27. doi: 10.1016/S0140-6736(14)60418-9. Epub 2014 Jun 16.
PubMed 24942631
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00821860
- Acronym / sponsor ID
- MesoVATS / P00804
- Conditions
- Malignant Mesothelioma, Metastatic Cancer
- Keywords
- epithelial mesothelioma, recurrent malignant mesothelioma, sarcomatous mesothelioma, malignant pleural effusion, stage IA malignant mesothelioma, stage IB malignant mesothelioma, stage II malignant mesothelioma, stage III malignant mesothelioma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- Sep 2003
- Primary completion
- Feb 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: therapeutic videothoracoscopyPatients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results. |
| Arm II | Active comparator | Other: talc, Procedure: therapeutic thoracoscopyPatients undergo talc pleurodesis via an indwelling intercostal chest drain or via thoracoscopy either at the time of biopsy or after confirmation of biopsy results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| talcTalc pleurodesis | Other | Arm II |
| therapeutic thoracoscopyTalc pleurodesis via thoracoscopy | Procedure or surgery | Arm II |
| therapeutic videothoracoscopyVideo-assisted thoracoscopic pleurectomy | Procedure or surgery | Arm I |
Primary outcome
Survival at 1 year after treatment
Time frame: 1 year
6 secondary outcomes
Control of pleural effusion
Time frame: 1 year
Complications, including need for more surgery, persistent air leak requiring pleural intubation for > 10 days, and hospital stay for > 12 days
Time frame: 1 year
Symptoms and quality of life as assessed by the EuroQol questionnaire
Time frame: 0, 1, 3, 6 12 months
Length of hospital stay
Time frame: 1 year
Exercise tolerance
Time frame: 0, 1, 3, 6 12 months
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
Time frame: 0, 1, 3, 6 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
- Derived from this study: PubMed 24942631Rintoul RC, Ritchie AJ, Edwards JG, Waller DA, Coonar AS, Bennett M, Lovato E, Hughes V, Fox-Rushby JA, Sharples LD; MesoVATS Collaborators. Efficacy and cost of video-assisted thoracoscopic partial pleurectomy versus talc pleurodesis in patients with malignant pleural mesothelioma (MesoVATS): an open-label, randomised, controlled trial. Lancet. 2014 Sep 20;384(9948):1118-27. doi: 10.1016/S0140-6736(14)60418-9. Epub 2014 Jun 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Winter, MD principal investigator
Papworth Hospital NHS Foundation Trust
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing talc, therapeutic thoracoscopy and therapeutic videothoracoscopy in people with Malignant Mesothelioma and Metastatic Cancer, run by Papworth Hospital NHS Foundation Trust at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at 1 year after treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00821860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2013.