Pleural Effusion, MalignantPhase 2NCT03394105
Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer
A Phase 2 study testing intrapleural docetaxel administration in people with Pleural Effusion, Malignant and Non-small Cell Carcinoma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
In this trial, the effect of intrapleural docetaxel administration using medical pleuroscopywill be evaluated in Lung Cancer patient with malignant effusion. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Pleural Effusion, Malignant, Non-small Cell Carcinoma
- What is being tested?
- intrapleural docetaxel administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jul 2016to 22 Jun 2018
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 20, and NSCLC patients with malignant pleural effusion and related symptoms
- ECOG ≤ 2
- Blood test ANC≥ 1500/mm3, Hb ≥ 8.0g/dl, platelet count ≥ 100000/mm3 Serum creatinine ≤ 1.8mg/dl, Total bilirubin within normal limits, Transaminases ≤ 1.5 x UNL, Alkaline phosphatase ≤ 2.5 X UNL BUN ≤ 25mg/dl, Creatinine clearance ≥ 50ml/min
- Negative serum or urine pregnancy test for women for childbearing age
- Patients who provide written informed consent for the study
Who cannot join
- Age < 20
- Patients who were previously perfomed pleurodesis
- Patients who were previously treated with thoracic radiosurgery
- Patinet with bilateral pleural effusion
- Age ≥ 80yrs
- Patients with histories of hypersensitivity to Docetaxel
- Patients with cardiovascular, respiratory, hepatic, renal, gastrointestinal, neunological disease, asthma, MI, stroke, arrhythmia, uncontrolled hypertionsion, etc. that would effect absorption, distribution, and metabolism of IP or be risk factors during IP administrion.
- Patients who could not understand the study procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Evaluate the Effect of Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer
In this trial, the effect of intrapleural docetaxel administration using medical pleuroscopywill be evaluated in Lung Cancer patient with malignant effusion.
Read the detailed description
This study is designed to be pilot, single-center, open-label, single-arm, prospective, phase II trial of patient with NSCLC with pleurla effusion. Approximately 40 patients will be enrolled into the trial, and study will be performed to 31Dec2018 from IRB and Korea: MFDS approval date.
Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer. Response evaluation will be done until confiramtion of disease progression.
- Being tested
- intrapleural docetaxel administration
- Keywords
- Pleurodesis
- 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.
intrapleural docetaxel administrationDrug
Also called Pleurodesis_docetaxel
intrapleural docetaxel administration using medical pleuroscopy in malignant effusion with lung cancer
| Study group | Role | What they receive |
|---|---|---|
| intrapleural docetaxel administration | Experimental | Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer. Receives: Drug: intrapleural docetaxel administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall respose rate(ORR)
Rate of CR and PR
Measured: through study completion (2.5 years)
Complete resonse (CR) rate
Measured: through study completion (2.5 years)
Secondary outcomes (3)
Time to progression(TTP)
time from the date of the start of treatment until the disease progression or death.
Measured: through study completion (2.5 years)
Overall survival(OS)
time fromthe date of the start of treatment to death or the date of last follow-up
Measured: through study completion (2.5 years)
Adverse Event
Based on National Cancer Institute Common Toxicity Criteria
Measured: through study completion (2.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start26 Jul 2016
- Primary completion22 Jun 2018
- Study completion22 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Effusion, MalignantStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Min Choi, Asan Medical Center
- Investigators
- CHANG-MIN CHOI, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394105
- Sponsor's protocol ID
- C2015-00353_Pleurodesis
- Status last verified
- Mar 2019
- First submitted
- 9 Oct 2017
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Effect of Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer
- ClinicalTrials.gov ID
- NCT03394105
- Acronym / sponsor ID
- C2015-00353_Pleurodesis
- Keywords
- Pleurodesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 26 Jul 2016 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 22 Jun 2018 (actual)
- First posted
- 9 Jan 2018 (actual)
- 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.
In this trial, the effect of intrapleural docetaxel administration using medical pleuroscopywill be evaluated in Lung Cancer patient with malignant effusion.
Detailed description
This study is designed to be pilot, single-center, open-label, single-arm, prospective, phase II trial of patient with NSCLC with pleurla effusion. Approximately 40 patients will be enrolled into the trial, and study will be performed to 31Dec2018 from IRB and Korea: MFDS approval date.
Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer. Response evaluation will be done until confiramtion of disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intrapleural docetaxel administration | Experimental | Drug: intrapleural docetaxel administrationDocetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 20, and NSCLC patients with malignant pleural effusion and related symptoms
- ECOG ≤ 2
- Blood test ANC≥ 1500/mm3, Hb ≥ 8.0g/dl, platelet count ≥ 100000/mm3 Serum creatinine ≤ 1.8mg/dl, Total bilirubin within normal limits, Transaminases ≤ 1.5 x UNL, Alkaline phosphatase ≤ 2.5 X UNL BUN ≤ 25mg/dl, Creatinine clearance ≥ 50ml/min
- Negative serum or urine pregnancy test for women for childbearing age
- Patients who provide written informed consent for the study
Key exclusion criteria (8 listed)
- Age < 20
- Patients who were previously perfomed pleurodesis
- Patients who were previously treated with thoracic radiosurgery
- Patinet with bilateral pleural effusion
- Age ≥ 80yrs
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 |
|---|---|---|
| intrapleural docetaxel administrationAlso: Pleurodesis_docetaxelintrapleural docetaxel administration using medical pleuroscopy in malignant effusion with lung cancer | Drug | intrapleural docetaxel administration |
Primary outcome
Overall respose rate(ORR)
Time frame: through study completion (2.5 years)
Rate of CR and PR
Complete resonse (CR) rate
Time frame: through study completion (2.5 years)
3 secondary outcomes
Time to progression(TTP)
Time frame: through study completion (2.5 years)
Overall survival(OS)
Time frame: through study completion (2.5 years)
Adverse Event
Time frame: through study completion (2.5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Individual participant dataSharing planned: Undecided
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RecruitingObservational study
UNC Pleural Fluid Registry
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Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
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RecruitingObservational study
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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.
CHANG-MIN CHOI, MD, PhD principal investigator
Asan Medical Center
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 intrapleural docetaxel administration in people with Pleural Effusion, Malignant and Non-small Cell Carcinoma, run by Asan Medical Center at 1 site in South Korea.
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 5 inclusion and 8 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 8 Mar 2019. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall respose rate(ORR) (time frame: through study completion (2.5 years)). The study lists 2 primary outcomes in all. 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 8 Mar 2019.