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

Information source: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malignant Mesothelioma; Metastatic Cancer

Intervention: talc (Other); therapeutic thoracoscopy (Procedure); therapeutic videothoracoscopy (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Papworth Hospital NHS Foundation Trust

Official(s) and/or principal investigator(s):
Robert Winter, MD, Principal Investigator, Affiliation: Papworth Hospital

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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Survival at 1 year after treatment

Secondary outcome:

Control of pleural effusion

Complications, including need for more surgery, persistent air leak requiring pleural intubation for > 10 days, and hospital stay for > 12 days

Symptoms and quality of life as assessed by the EuroQol questionnaire

Length of hospital stay

Exercise tolerance

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

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

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

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

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

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: September 2003
Last updated: June 27, 2013

Page last updated: August 23, 2015

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