Malignant Pleural EffusionPhase 2NCT02054078
Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion
A Phase 2 study testing Bevacizumab and Pulvis talci in people with Malignant Pleural Effusion, run by Tang-Du Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- Bevacizumab and Pulvis talci
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnose malignant pleural effusions by:
- Diagnose malignant pleural neoplasms by histopathology
- Recurrent pleural effusion, Histologically or cytologically confirmed diagnosis of cancer
- Written informed consent
Who cannot join
- <18years of age
- Expected survival <3 months
- Chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once
- Planned chemotherapy
- Pregnancy or breast-feeding (women of child-bearing potential)
- Not signed informed consent or non-compliance with treatment protocols
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi
qiang lu, doctor, 18092920605, luqiang@fmmu.edu.cn
About this study
Official title: Efficacy and Safety of Intrapleural Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion, A Randomized, Multicenter Study
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.
Read the 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.
- Conditions
- Malignant Pleural Effusion
- Being tested
- Bevacizumab, Pulvis talci
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab200mg by intrapleural administration
Pulvis talciDrug
Pulvis talci 4g by intrapleural administration
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Bevacizumab200mg by intrapleural administration Receives: Drug: Bevacizumab |
| Pulvis talci | Active comparator | Pulvis talci 4g by intrapleural administration Receives: Drug: Pulvis talci |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in chest drainage
Observed chest drainage every day
Measured: up to 3months
Secondary outcomes (4)
the average daily VAS defining breathlessness
VAS: Visual Analogue Scale
Measured: up to 1 year
Average daily thoracalgia assessed using VAS score
VAS: Visual Analogue Scale
Measured: up to 1 year
percentage of adverse reactions
Measured: up to 1 year
Length of Stay
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startJan 2012
- Primary completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofei Li, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054078
- Sponsor's protocol ID
- CTSL002
- Status last verified
- Feb 2014
- First submitted
- 28 Jan 2014
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intrapleural Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion, A Randomized, Multicenter Study
- ClinicalTrials.gov ID
- NCT02054078
- Acronym / sponsor ID
- CTSL002
- Conditions
- Malignant Pleural Effusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2014 (estimated)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: BevacizumabBevacizumab200mg by intrapleural administration |
| Pulvis talci | Active comparator | Drug: Pulvis talciPulvis talci 4g by intrapleural administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnose malignant pleural effusions by:
- Written informed consent
Key exclusion criteria (6 listed)
- <18years of age
- Expected survival <3 months
- Chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once
- Planned chemotherapy
- Pregnancy or breast-feeding (women of child-bearing potential)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab200mg by intrapleural administration | Drug | Bevacizumab |
| Pulvis talciPulvis talci 4g by intrapleural administration | Drug | Pulvis talci |
Primary outcome
Changes in chest drainage
Time frame: up to 3months
Observed chest drainage every day
4 secondary outcomes
the average daily VAS defining breathlessness
Time frame: up to 1 year
Average daily thoracalgia assessed using VAS score
Time frame: up to 1 year
percentage of adverse reactions
Time frame: up to 1 year
Length of Stay
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and Pulvis talci in people with Malignant Pleural Effusion, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiaofei li, doctor (13909111010, lxfchest@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in chest drainage (time frame: up to 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.