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

Sponsor:	Papworth Hospital
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00821860

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 thoracoscopic surgery Procedure: therapeutic thoracoscopy Procedure: therapeutic videothoracoscopy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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:

MedlinePlus related topics: Cancer Mesothelioma Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Survival at 1 year after treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Control of pleural effusion [ 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 [ Designated as safety issue: No ]
Symptoms and quality of life as assessed by the EuroQol questionnaire [ Designated as safety issue: No ]
Length of hospital stay [ Designated as safety issue: No ]
Exercise tolerance [ 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 [ Designated as safety issue: No ]

Estimated Enrollment:	196
Study Start Date:	September 2003
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.	Procedure: therapeutic thoracoscopic surgery Video-assisted thoracoscopic pleurectomy Procedure: therapeutic videothoracoscopy Video-assisted thoracoscopic pleurectomy
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.	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, England
Basildon University Hospital	Recruiting
Basildon, England, United Kingdom, SS16 5NL
Contact: Contact Person 44-1268-533-911
Glenfield Hospital	Recruiting
Leicester, England, United Kingdom, LE3 9QP
Contact: Contact Person 44-116-287-1471
Guy's Hospital	Recruiting
London, England, United Kingdom, SE1 9RT
Contact: Contact Person 44-20-7188-7188
Papworth Hospital	Recruiting
Cambridge, England, United Kingdom, CB3 8RE
Contact: Contact Person 44-1480-364-821
Royal Hallamshire Hospital	Recruiting
Sheffield, England, United Kingdom, S1O 2JF
Contact: Contact Person 44-114-271-1900

Sponsors and Collaborators

Papworth Hospital

Investigators

Principal Investigator:

Robert Winter, MD

Papworth Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000630699, PAPWORTH-MESOVATS, PAPWORTH-P00804, EU-20901, ISRCTN34321019
Study First Received:	January 13, 2009
Last Updated:	January 12, 2010
ClinicalTrials.gov Identifier:	NCT00821860 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

advanced malignant mesothelioma
epithelial mesothelioma
localized malignant mesothelioma

recurrent malignant mesothelioma
sarcomatous mesothelioma
malignant pleural effusion

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms, Mesothelial

Neoplasm Metastasis
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 09, 2010