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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02054078
Recruitment Status : Unknown
Verified February 2014 by Xiaofei Li, Tang-Du Hospital.
Recruitment status was:  Recruiting
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Xiaofei Li, Tang-Du Hospital

Tracking Information
First Submitted Date  ICMJE January 28, 2014
First Posted Date  ICMJE February 4, 2014
Last Update Posted Date February 4, 2014
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2014)
Changes in chest drainage [ Time Frame: up to 3months ]
Observed chest drainage every day
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2014)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion
Official Title  ICMJE 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 Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Pleural Effusion
Intervention  ICMJE
  • Drug: Bevacizumab
    Bevacizumab200mg by intrapleural administration
    Other Name: Avastin
  • Drug: Pulvis talci
    Pulvis talci 4g by intrapleural administration
Study Arms  ICMJE
  • Experimental: Bevacizumab
    Bevacizumab200mg by intrapleural administration
    Intervention: Drug: Bevacizumab
  • Active Comparator: Pulvis talci
    Pulvis talci 4g by intrapleural administration
    Intervention: Drug: Pulvis talci
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 3, 2014)
183
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnose malignant pleural effusions by:

    • Diagnose malignant pleural neoplasms by histopathology
    • Recurrent pleural effusion, Histologically or cytologically confirmed diagnosis of cancer
  2. Written informed consent

Exclusion Criteria:

  1. <18years of age
  2. Expected survival <3 months
  3. Chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once
  4. Planned chemotherapy
  5. Pregnancy or breast-feeding (women of child-bearing potential)
  6. Not signed informed consent or non-compliance with treatment protocols
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02054078
Other Study ID Numbers  ICMJE CTSL002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiaofei Li, Tang-Du Hospital
Study Sponsor  ICMJE Tang-Du Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tang-Du Hospital
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP