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

Malignant Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02054078
• Other study ID #: CTSL002
• 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. 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

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

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