Clinical trial NCT02054078: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Malignant Pleural Effusion
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in chest drainage
timeFrame: up to 3months
Secondary outcomes:
measure: the average daily VAS defining breathlessness
timeFrame: up to 1 year
measure: Average daily thoracalgia assessed using VAS score
timeFrame: up to 1 year
measure: percentage of adverse reactions
timeFrame: up to 1 year
measure: Length of Stay
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
References: