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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02054078
Other study ID # CTSL002
Secondary ID
Status Recruiting
Phase Phase 2
First received January 28, 2014
Last updated February 3, 2014
Start date January 2012

Study information

Verified date February 2014
Source Tang-Du Hospital
Contact xiaofei li, doctor
Phone 13909111010
Email lxfchest@fmmu.edu.cn
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 183
Est. completion date
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Bevacizumab
Bevacizumab200mg by intrapleural administration
Pulvis talci
Pulvis talci 4g by intrapleural administration

Locations

Country Name City State
China Tangdu Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in chest drainage Observed chest drainage every day up to 3months Yes
Secondary the average daily VAS defining breathlessness VAS: Visual Analogue Scale up to 1 year Yes
Secondary Average daily thoracalgia assessed using VAS score VAS: Visual Analogue Scale up to 1 year Yes
Secondary percentage of adverse reactions up to 1 year Yes
Secondary Length of Stay up to 1 year Yes
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