Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion
Primary Purpose
Malignant Pleural Effusion
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bevacizumab
Pulvis talci
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Pleural Effusion
Eligibility Criteria
Inclusion Criteria:
Diagnose malignant pleural effusions by:
- Diagnose malignant pleural neoplasms by histopathology
- Recurrent pleural effusion, Histologically or cytologically confirmed diagnosis of cancer
- Written informed consent
Exclusion Criteria:
- <18years of age
- Expected survival <3 months
- Chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once
- Planned chemotherapy
- Pregnancy or breast-feeding (women of child-bearing potential)
- Not signed informed consent or non-compliance with treatment protocols
Sites / Locations
- Tangdu HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bevacizumab
Pulvis talci
Arm Description
Bevacizumab200mg by intrapleural administration
Pulvis talci 4g by intrapleural administration
Outcomes
Primary Outcome Measures
Changes in chest drainage
Observed chest drainage every day
Secondary Outcome Measures
the average daily VAS defining breathlessness
VAS: Visual Analogue Scale
Average daily thoracalgia assessed using VAS score
VAS: Visual Analogue Scale
percentage of adverse reactions
Length of Stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02054078
Brief Title
Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion
Official Title
Efficacy and Safety of Intrapleural Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion, A Randomized, Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tang-Du Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
183 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab
Arm Type
Experimental
Arm Description
Bevacizumab200mg by intrapleural administration
Arm Title
Pulvis talci
Arm Type
Active Comparator
Arm Description
Pulvis talci 4g by intrapleural administration
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab200mg by intrapleural administration
Intervention Type
Drug
Intervention Name(s)
Pulvis talci
Intervention Description
Pulvis talci 4g by intrapleural administration
Primary Outcome Measure Information:
Title
Changes in chest drainage
Description
Observed chest drainage every day
Time Frame
up to 3months
Secondary Outcome Measure Information:
Title
the average daily VAS defining breathlessness
Description
VAS: Visual Analogue Scale
Time Frame
up to 1 year
Title
Average daily thoracalgia assessed using VAS score
Description
VAS: Visual Analogue Scale
Time Frame
up to 1 year
Title
percentage of adverse reactions
Time Frame
up to 1 year
Title
Length of Stay
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnose malignant pleural effusions by:
Diagnose malignant pleural neoplasms by histopathology
Recurrent pleural effusion, Histologically or cytologically confirmed diagnosis of cancer
Written informed consent
Exclusion Criteria:
<18years of age
Expected survival <3 months
Chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once
Planned chemotherapy
Pregnancy or breast-feeding (women of child-bearing potential)
Not signed informed consent or non-compliance with treatment protocols
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaofei li, doctor
Phone
13909111010
Email
lxfchest@fmmu.edu.cn
Facility Information:
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qiang lu, doctor
Phone
18092920605
Email
luqiang@fmmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion
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