- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01661790
Intrapleural Bevacizumab and Cisplatin Therapy for Malignant Pleural Effusion Caused by Non-small Cell Lung Cancer
March 13, 2015 updated by: DuNan, Chinese PLA General Hospital
Open-labeled, Randomized, Multicenter Phase III Study of Adjuvant Chemotherapy Comparing Bevacizumab Plus Cisplatin With Cisplatin Regimen in Malignant Pleural Effusion of Advanced Stage Non-Small-Cell Lung Cancer Patients
To determine the efficacy and Safety of intrapleural Bevacizumab and cisplatin as a treatment for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100048
- PLA 304 hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with advanced recurrent or progressive NSCLC proven cytohistologically
- Karnofsky performance status (KPS) ≥60
- Life expectancy ≥ 2 months
- No history of severe diseases of major organs including liver, heart, and kidney
- No previous intrapleural therapy
- Written informed consent
Exclusion Criteria:
- Active thoracic cavity or systemic bleeding
- Active pleural or systemic infection.
- Known sensitivity to Bevacizumab or Cisplatin
- Refusal to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bevacizumab & Cisplatin
Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks
|
Bevacizumab300mg&Cispltin30mg by intrapleural administration of each 2 week
Other Names:
Cisplatin 30mg,intrapleural administration,each 2 week
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Active Comparator: Cisplatin
Cisplatin 30mg by intrapleural given every two weeks
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Cisplatin 30mg,intrapleural administration,each 2 week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With "Complete Response" and "Partial Response"
Time Frame: from randomization, This treatment was given every two weeks,responses were made by biweekly
|
Response assessed by type-B ultrasonic tests; Complete remission (CR) was considered when the accumulated fluid had disappeared and was stable for at least four weeks; partial remission (PR) was considered when >50% of the accumulated fluid had disappeared, symptoms had improved, and the remaining fluid had failed to increase for at least four weeks; The total efficiency ORR was calculated by taking the sum of CR+PR
|
from randomization, This treatment was given every two weeks,responses were made by biweekly
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Median Progression Free Survival (PFS)
Time Frame: baseline to biweekly,until disease progression
|
baseline to biweekly,until disease progression
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Overall Survival (OS)
Time Frame: randomization to four weeks,until death
|
randomization to four weeks,until death
|
Adverse Reactions
Time Frame: Up to 1 month after the last treatment
|
Up to 1 month after the last treatment
|
Qualify of Life (QoL)
Time Frame: baseline to biweekly,until death
|
baseline to biweekly,until death
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A)
Time Frame: before intrapleural administration
|
before intrapleural administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nan Du, PLA 304 hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
July 25, 2012
First Submitted That Met QC Criteria
August 6, 2012
First Posted (Estimate)
August 10, 2012
Study Record Updates
Last Update Posted (Estimate)
March 25, 2015
Last Update Submitted That Met QC Criteria
March 13, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Pleural Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Pleural Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Pleural Effusion, Malignant
- Pleural Effusion
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Cisplatin
- Bevacizumab
Other Study ID Numbers
- PLA304DN-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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