Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion
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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
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Tracking Information | |||
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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 |
Changes in chest drainage [ Time Frame: up to 3months ] Observed chest drainage every day
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE |
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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. |
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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 |
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Condition ICMJE | Malignant Pleural Effusion | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Unknown status | ||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |