Malignant Pleural EffusionPhase 3NCT01661790
Intrapleural Bevacizumab and Cisplatin Therapy for Malignant Pleural Effusion Caused by Non-small Cell Lung Cancer
A Phase 3 study testing Bevacizumab and Cisplatin in people with Malignant Pleural Effusion, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- Bevacizumab and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Oct 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active thoracic cavity or systemic bleeding
- Active pleural or systemic infection.
- Known sensitivity to Bevacizumab or Cisplatin
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Malignant Pleural Effusion
- Being tested
- Bevacizumab, Cisplatin
- Keywords
- Bevacizumab;, non-small cell lung cancer;, malignant pleural effusion;, intrapleural administration
- Medical subject headings
- Pleural Effusion, Malignant, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab300mg\&Cispltin30mg by intrapleural administration of each 2 week
CisplatinDrug
Cisplatin 30mg,intrapleural administration,each 2 week
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab & Cisplatin | Experimental | Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks Receives: Drug: Bevacizumab; Drug: Cisplatin |
| Cisplatin | Active comparator | Cisplatin 30mg by intrapleural given every two weeks Receives: Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With "Complete Response" and "Partial Response"
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
Measured: from randomization, This treatment was given every two weeks,responses were made by biweekly
Secondary outcomes (4)
Median Progression Free Survival (PFS)
Measured: baseline to biweekly,until disease progression
Overall Survival (OS)
Measured: randomization to four weeks,until death
Adverse Reactions
Measured: Up to 1 month after the last treatment
Qualify of Life (QoL)
Measured: baseline to biweekly,until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startAug 2009
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, DuNan, Chinese PLA General Hospital
- Investigators
- Nan Du, Principal investigator, PLA 304 hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661790
- Sponsor's protocol ID
- PLA304DN-001
- Status last verified
- Mar 2015
- First submitted
- 25 Jul 2012
- Last updated
- 25 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01661790
- Acronym / sponsor ID
- PLA304DN-001
- Conditions
- Malignant Pleural Effusion
- Keywords
- Bevacizumab;, non-small cell lung cancer;, malignant pleural effusion;, intrapleural administration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Aug 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Posted 25 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab & Cisplatin | Experimental | Drug: Bevacizumab, Drug: CisplatinBevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks |
| Cisplatin | Active comparator | Drug: CisplatinCisplatin 30mg by intrapleural given every two weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Active thoracic cavity or systemic bleeding
- Active pleural or systemic infection.
- Known sensitivity to Bevacizumab or Cisplatin
- Refusal to participate in the study.
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: AvastinBevacizumab300mg\&Cispltin30mg by intrapleural administration of each 2 week | Drug | Bevacizumab & Cisplatin |
| CisplatinCisplatin 30mg,intrapleural administration,each 2 week | Drug | Bevacizumab & Cisplatin, Cisplatin |
Primary outcome
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
4 secondary outcomes
Median Progression Free Survival (PFS)
Time frame: baseline to biweekly,until disease progression
Overall Survival (OS)
Time frame: randomization to four weeks,until death
Adverse Reactions
Time frame: Up to 1 month after the last treatment
Qualify of Life (QoL)
Time frame: baseline to biweekly,until death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Malignant Pleural Effusion
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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.
Nan Du principal investigator
PLA 304 hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevacizumab and Cisplatin in people with Malignant Pleural Effusion, run by Chinese PLA General 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 25 Mar 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 25 Mar 2015.