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

NCT00821860 | Completed Phase 3 DMC

• 5 other identifiers: P00804PAPWORTH-MESOVATSPAPWORTH-P00804EU-20901ISRCTN34321019
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• Survival at 1 year after treatment

  1 year

Secondary Outcomes (6)

• Control of pleural effusion

  1 year

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

  1 year

• Symptoms and quality of life as assessed by the EuroQol questionnaire

  0, 1, 3, 6 12 months

• Length of hospital stay

  1 year

• Exercise tolerance

  0, 1, 3, 6 12 months

Study Arms (2)

Arm I

EXPERIMENTAL

Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.

Procedure: therapeutic videothoracoscopy

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; Procedure: therapeutic thoracoscopy

Interventions

talc OTHER

Talc pleurodesis

Arm II

therapeutic thoracoscopy PROCEDURE

Talc pleurodesis via thoracoscopy

Arm II

therapeutic videothoracoscopy PROCEDURE

Video-assisted thoracoscopic pleurectomy

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (5)

Basildon University Hospital

Basildon, England, SS16 5NL, United Kingdom

Location

Papworth Hospital

Cambridge, England, CB3 8RE, United Kingdom

Location

Glenfield Hospital

Leicester, England, LE3 9QP, United Kingdom

Location

Guy's Hospital

London, England, SE1 9RT, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, England, S1O 2JF, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24942631 DERIVED

MeSH Terms

Conditions

Mesothelioma, Malignant; Neoplasm Metastasis; Solitary Fibrous Tumor, Pleural; Pleural Effusion, Malignant

Interventions

Talc

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Solitary Fibrous Tumors; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Pleural Effusion; Pleural Diseases

Intervention Hierarchy (Ancestors)

Magnesium Silicates; Magnesium Compounds; Inorganic Chemicals; Silicates; Minerals; Silicic Acid; Silicon Dioxide; Silicon Compounds

Study Officials

• Robert Winter, MD

  Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: September 1, 2003
• Primary Completion: February 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

GB (5)