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

Sponsored by:Papworth Hospital NHS Foundation Trust
Information provided:Papworth Hospital NHS Foundation Trust
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 thoracoscopy
Procedure: therapeutic videothoracoscopy
Phase 3

Eligibility

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

Additional Details:


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.

Enrollment Size: Both

Gender: 18 Years

Min. Age: N/A

Max. Age: No

Location and Contact Information

United Kingdom, England
Basildon University Hospital, Basildon, England, SS16 5NL, United Kingdom
Status:

United Kingdom, England
Papworth Hospital, Cambridge, England, CB3 8RE, United Kingdom
Status:

United Kingdom, England
Glenfield Hospital, Leicester, England, LE3 9QP, United Kingdom
Status:

United Kingdom, England
Guy's Hospital, London, England, SE1 9RT, United Kingdom
Status:

United Kingdom, England
Royal Hallamshire Hospital, Sheffield, England, S1O 2JF, United Kingdom
Status:

Last modified: April 19, 2014.