Malignant HydrothoraxPhase 3NCT02579564
Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients
A Phase 3 study testing Gemcitabine, Vinorelbine and Paclitaxel in people with Malignant Hydrothorax and Non Small Cell Lung Cancer, run by Xinqiao Hospital of Chongqing.
Trial summary
The purpose of this multi-center clinical trial is to verify more effective on local control of malignant pleural effusions in NSCLC patients by thoracic cavity perfusion of recombinant human adenovirus type 5 injection and recombinant human Endostatin injection (Endostar) compared with cisplatin perfusion, with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Hydrothorax, Non Small Cell Lung Cancer
- What is being tested?
- Gemcitabine, Vinorelbine and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Dec 2018
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-75 yrs;
- Kamofsky score (KPS) ≥70, and a predicted lifespan >3 months;
- Enough function of vital organs, such as heart, liver and kidney;
- Advanced NSCLC diagnosed by cytology or pathology
- Unilateral or bilateral of malignant pleural effusion in the first time;
- Patients who are considered as malignant pleural effusion by cytology or biomarkers (CEA, CA199, CA125) in pleural effusion;
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- Without systemic infection or high fever;
- Without active EGFR mutation or unwilling to targeted molecular therapy;
- NO Anti tumor Radiotherapy chemotherapy and molecular targeted therapy,or Received Anti tumor Radiotherapy chemotherapy and molecular and clinical remission more than three months and in the past month ,disease progress with pleural cavity effusion but haven't use systemic or local anti tumor treatment.
- No pleural cavity injection of antineoplastic drugs.
Who cannot join
- Non-malignant pleural effusion;
- Pleural effusion cause by other malignant tumors;
- Allergic to Recombinant human adenovirus type 5 injection or Endostar;
- Pregnant or lactation women;
- Previously using Medicine for treating NSCLC with pleural cavity effusion by Systemic or pleural cavity perfusion treatment one month prior to enrollment;
- Previously using the diuretics, albumin and anti-angiogenesis drugs, or dexamethasone one month prior to enrollment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Systemic Chemotherapy Combined With Thoracic Cavity Perfusion of Recombinant Human Adenovirus Type 5 and Endostatin Injections Versus Cisplatin for Treatment Malignant Hydrothorax in Non Small Cell Lung Cancer (NSCLC) Patients: A Multi-center, Randomized, Controlled Clinical Trial
The purpose of this multi-center clinical trial is to verify more effective on local control of malignant pleural effusions in NSCLC patients by thoracic cavity perfusion of recombinant human adenovirus type 5 injection and recombinant human Endostatin injection (Endostar) compared with cisplatin perfusion, with acceptable side effects.
Read the detailed description
Malignant pleural effusion, which can malfunction of circulatory and respiratory systems, is a common complication in advanced NSCLC, finally decreases the quality of life and lifespan. Nowadays, it is still a challenge to effectively control malignant pleural effusion. In this multi-center randomized and controlled clinical trial, 134 NSCLC patients diagnosed as malignant pleural effusion in the first time will enroll. Based on systemic chemotherapy and pleural cavity perfusion, all eligible patients are randomly assigned into treatment group (recombinant human adenovirus type 5 and Endostatin injections) and control group (cisplatin) with ratio 1:1. Local control rate and side effects are record respectively. The anticipation is that treatment group obtains faster and longer control of pleural effusion.
- Conditions
- Malignant Hydrothorax, Non Small Cell Lung Cancer
- Being tested
- Gemcitabine, Vinorelbine, Paclitaxel, Pemetrexed, Oncorine
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
VinorelbineDrug
PaclitaxelDrug
PemetrexedDrug
OncorineDrug
Also called recombinant human adenovirus type 5 injection
EndostarDrug
Also called recombinant human endostatin injection
CisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy with Oncorine and Endostar | Experimental | Systemic chemotherapy with standard schemes, such as GP (Gemcitabine/Cisplatin), NP (Vinorelbine/Cisplatin), TP (Paclitaxel/Cisplatin) or PP (Pemetrexed/Cisplatin). Thoracic cavity perfusion of recombinant human adenovirus type 5 injection 1.5ml and Endostar 30mg each time, twice a week for four times. Receives: Drug: Gemcitabine; Drug: Vinorelbine; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Oncorine; Drug: Endostar; Drug: Cisplatin |
| chemotherapy with cisplatin | Active comparator | Systemic chemotherapy with standard schemes without cisplatin, such as Gemcitabine, Vinorelbine, Paclitaxel or Pemetrexed. Thoracic cavity perfusion of cisplatin 30mg/m2 each time, twice a week for four times. Receives: Drug: Gemcitabine; Drug: Vinorelbine; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) of malignant pleural effusions
Assessed by WHO Cancerous effusion scoring system
Measured: up to 3 years
Secondary outcomes (1)
progression-free survival
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startOct 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant HydrothoraxStudies of the same condition, open and under way.
- 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
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengtang Chen, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579564
- Sponsor's protocol ID
- CTAEMTF
- Status last verified
- Oct 2016
- First submitted
- 12 Oct 2015
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Chemotherapy Combined With Thoracic Cavity Perfusion of Recombinant Human Adenovirus Type 5 and Endostatin Injections Versus Cisplatin for Treatment Malignant Hydrothorax in Non Small Cell Lung Cancer (NSCLC) Patients: A Multi-center, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02579564
- Acronym / sponsor ID
- CTAEMTF
- Conditions
- Malignant Hydrothorax, Non Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Oct 2015 (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.
The purpose of this multi-center clinical trial is to verify more effective on local control of malignant pleural effusions in NSCLC patients by thoracic cavity perfusion of recombinant human adenovirus type 5 injection and recombinant human Endostatin injection (Endostar) compared with cisplatin perfusion, with acceptable side effects.
Detailed description
Malignant pleural effusion, which can malfunction of circulatory and respiratory systems, is a common complication in advanced NSCLC, finally decreases the quality of life and lifespan. Nowadays, it is still a challenge to effectively control malignant pleural effusion. In this multi-center randomized and controlled clinical trial, 134 NSCLC patients diagnosed as malignant pleural effusion in the first time will enroll. Based on systemic chemotherapy and pleural cavity perfusion, all eligible patients are randomly assigned into treatment group (recombinant human adenovirus type 5 and Endostatin injections) and control group (cisplatin) with ratio 1:1. Local control rate and side effects are record respectively. The anticipation is that treatment group obtains faster and longer control of pleural effusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemotherapy with Oncorine and Endostar | Experimental | Drug: Gemcitabine, Drug: Vinorelbine, Drug: Paclitaxel, Drug: Pemetrexed, Drug: Oncorine, Drug: Endostar, Drug: CisplatinSystemic chemotherapy with standard schemes, such as GP (Gemcitabine/Cisplatin), NP (Vinorelbine/Cisplatin), TP (Paclitaxel/Cisplatin) or PP (Pemetrexed/Cisplatin). Thoracic cavity perfusion of recombinant human adenovirus type 5 injection 1.5ml and Endostar 30mg each time, twice a week for four times. |
| chemotherapy with cisplatin | Active comparator | Drug: Gemcitabine, Drug: Vinorelbine, Drug: Paclitaxel, Drug: Pemetrexed, Drug: CisplatinSystemic chemotherapy with standard schemes without cisplatin, such as Gemcitabine, Vinorelbine, Paclitaxel or Pemetrexed. Thoracic cavity perfusion of cisplatin 30mg/m2 each time, twice a week for four times. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- age 18-75 yrs;
- Kamofsky score (KPS) ≥70, and a predicted lifespan >3 months;
- Enough function of vital organs, such as heart, liver and kidney;
- Advanced NSCLC diagnosed by cytology or pathology
- Unilateral or bilateral of malignant pleural effusion in the first time;
Key exclusion criteria (6 listed)
- Non-malignant pleural effusion;
- Pleural effusion cause by other malignant tumors;
- Allergic to Recombinant human adenovirus type 5 injection or Endostar;
- Pregnant or lactation women;
- Previously using Medicine for treating NSCLC with pleural cavity effusion by Systemic or pleural cavity perfusion treatment one month prior to enrollment;
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 |
|---|---|---|
| Gemcitabine | Drug | chemotherapy with Oncorine and Endostar, chemotherapy with cisplatin |
| Vinorelbine | Drug | chemotherapy with Oncorine and Endostar, chemotherapy with cisplatin |
| Paclitaxel | Drug | chemotherapy with Oncorine and Endostar, chemotherapy with cisplatin |
| Pemetrexed | Drug | chemotherapy with Oncorine and Endostar, chemotherapy with cisplatin |
| OncorineAlso: recombinant human adenovirus type 5 injection | Drug | chemotherapy with Oncorine and Endostar |
| EndostarAlso: recombinant human endostatin injection | Drug | chemotherapy with Oncorine and Endostar |
| Cisplatin | Drug | chemotherapy with Oncorine and Endostar, chemotherapy with cisplatin |
Primary outcome
Objective response rate (ORR) of malignant pleural effusions
Time frame: up to 3 years
Assessed by WHO Cancerous effusion scoring system
1 secondary outcome
progression-free survival
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemcitabine, Vinorelbine and Paclitaxel in people with Malignant Hydrothorax and Non Small Cell Lung Cancer, run by Xinqiao Hospital of Chongqing.
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 10 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ZhengTang Chen, PHD (+862368755625, 1240887467@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) of malignant pleural effusions (time frame: up to 3 years). 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 21 Oct 2016.