Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma (MesoVATS)
This study is ongoing, but not recruiting participants.
Sponsor:
Papworth Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00821860
First received: January 13, 2009
Last updated: March 30, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma Metastatic Cancer |
Other: talc Procedure: therapeutic thoracoscopy Procedure: therapeutic videothoracoscopy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Papworth Hospital NHS Foundation Trust:
Primary Outcome Measures:
- Survival at 1 year after treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Control of pleural effusion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Symptoms and quality of life as assessed by the EuroQol questionnaire [ Time Frame: 0, 1, 3, 6 12 months ] [ Designated as safety issue: No ]
- Length of hospital stay [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Exercise tolerance [ Time Frame: 0, 1, 3, 6 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 196 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.
|
Procedure: therapeutic videothoracoscopy
Video-assisted thoracoscopic pleurectomy
|
|
Active Comparator: Arm II
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.
|
Other: talc
Talc pleurodesis
Procedure: therapeutic thoracoscopy
Talc pleurodesis via thoracoscopy
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821860
Locations
| United Kingdom | |
| Basildon University Hospital | |
| Basildon, England, United Kingdom, SS16 5NL | |
| Papworth Hospital | |
| Cambridge, England, United Kingdom, CB3 8RE | |
| Glenfield Hospital | |
| Leicester, England, United Kingdom, LE3 9QP | |
| Guy's Hospital | |
| London, England, United Kingdom, SE1 9RT | |
| Royal Hallamshire Hospital | |
| Sheffield, England, United Kingdom, S1O 2JF | |
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Investigators
| Principal Investigator: | Robert Winter, MD | Papworth Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Papworth Hospital NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00821860 History of Changes |
| Other Study ID Numbers: | P00804, PAPWORTH-MESOVATS, PAPWORTH-P00804, EU-20901, ISRCTN34321019 |
| Study First Received: | January 13, 2009 |
| Last Updated: | March 30, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Papworth Hospital NHS Foundation Trust:
|
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 |
Additional relevant MeSH terms:
|
Mesothelioma Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Adenoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013