Clinical Trial: Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficacy and Safety of Intrapleural Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion, A Randomized, Multicenter Study

Brief Summary: Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.

Detailed Summary:

Background： Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.

Methods:

A unblended, randomized study to compare the inhibition of two treatment methods in malignant pleural effusion. Consecutive 183 patients were randomly assigned to two groups, A group is Bevacizumab200mg by intrapleural administration; B group is injected pulvis talci with closed thoracic drainage.


Sponsor: Tang-Du Hospital

Current Primary Outcome: Changes in chest drainage [ Time Frame: up to 3months ]

Observed chest drainage every day


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • the average daily VAS defining breathlessness [ Time Frame: up to 1 year ]
    VAS: Visual Analogue Scale
  • Average daily thoracalgia assessed using VAS score [ Time Frame: up to 1 year ]
    VAS: Visual Analogue Scale
  • percentage of adverse reactions [ Time Frame: up to 1 year ]
  • Length of Stay [ Time Frame: up to 1 year ]


Original Secondary Outcome: Same as current

Information By: Tang-Du Hospital

Dates:
Date Received: January 28, 2014
Date Started: January 2012
Date Completion:
Last Updated: February 3, 2014
Last Verified: February 2014