Clinical trial NCT00821860: Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
stage IV malignant mesothelioma
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2009-01-14
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility 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

Primary outcomes:
measure: Survival at 1 year after treatment
timeFrame: 1 year
Secondary outcomes:
measure: Control of pleural effusion
timeFrame: 1 year
measure: Complications, including need for more surgery, persistent air leak requiring pleural intubation for > 10 days, and hospital stay for > 12 days
timeFrame: 1 year
measure: Symptoms and quality of life as assessed by the EuroQol questionnaire
timeFrame: 0, 1, 3, 6 12 months
measure: Length of hospital stay
timeFrame: 1 year
measure: Exercise tolerance
timeFrame: 0, 1, 3, 6 12 months
measure: 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
timeFrame: 0, 1, 3, 6 12 months
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
state: England
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
state: England
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
state: England
city: London
country: United Kingdom
facility: Guy's Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: England
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: Robert Winter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.