Pleural Effusion, MalignantNCT02407912
Cisplatin for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer
A study testing cisplatin in people with Pleural Effusion, Malignant, run by Shantou University Medical College at 1 site in China.
Trial summary
To assess the effect and toxicity of intrapleural administration of hypertonic cisplatin for malignant pleural effusion in patients with non-small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pleural Effusion, Malignant
- What is being tested?
- cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Mar 2020
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytologically proven and previously untreated malignant pleural effusion of Non-small-cell Lung Cancer;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1;
- A leucocyte count of≥4000µl;
- A platelet count of≥100000µl;
- A normal creatinine level;
- Serum glutamic oxaloacetic transaminase/glutamic pyruvic transaminase levels of no more than twice the upper limit of normal;
- Survival time ≥12 weeks.
Who cannot join
- Previously treated malignant pleural effusion;
- Pericardial effusion；
- Pregnant；
- Uncontrolled hypertension or diabetes；
- Liver cihrosis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of medical oncology
Shantou, Guangdong, 515031
Hongbiao Wang, Master, 8613592882093, wanghongbiao123@qq.com
About this study
Official title: Intrapleural Hypertonic Cisplatin Treatment for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer.
To assess the effect and toxicity of intrapleural administration of hypertonic cisplatin for malignant pleural effusion in patients with non-small-cell lung cancer.
Read the detailed description
The lung was fully expanded by a thoracostomy using a chest tube with a double lumen, and then the patients were enrolled into the trial.First, premedication including antiemetics and hydration were performed. Thereafter, 75 mg of body surface area of cisplatin in 50 ml of distilled water was injected through a chest tube.The patients were asked to change position (supine and bilateral decubital) from time to time for 30 minutes. The chest tube was clamped for 48 h and then the tube was declamped and allowed to drain. When the drainage effusion was less than 100 ml a day, the chest tube was removed. Any patient whose drainage effusion continued for over 2 weeks was withdrawn from the trial and was also judged to be a nonresponder.
- Conditions
- Pleural Effusion, Malignant
- Being tested
- cisplatin
- 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.
cisplatinDrug
Also called cisplatinum
ciplatin in distilled water is injected into the chest for 48 h.
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin | Experimental | 75 mg of body surface area of ciplatin in distilled water is injected in to the chest through a chesttube. Receives: Drug: cisplatin |
| Control | No intervention | No intervention was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2018 (estimated)
- Study completionMar 2020 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shantou University Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongbiao Wang, Shantou University Medical College
- Investigators
- Hongbiao Wang, Master, Principal investigator, Affiliated Cancer Hospital of Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407912
- Sponsor's protocol ID
- LXY 01
- Status last verified
- Nov 2015
- First submitted
- 31 Mar 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapleural Hypertonic Cisplatin Treatment for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT02407912
- Acronym / sponsor ID
- LXY 01
- Conditions
- Pleural Effusion, Malignant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shantou University Medical CollegeUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 3 Apr 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.
To assess the effect and toxicity of intrapleural administration of hypertonic cisplatin for malignant pleural effusion in patients with non-small-cell lung cancer.
Detailed description
The lung was fully expanded by a thoracostomy using a chest tube with a double lumen, and then the patients were enrolled into the trial.First, premedication including antiemetics and hydration were performed. Thereafter, 75 mg of body surface area of cisplatin in 50 ml of distilled water was injected through a chest tube.The patients were asked to change position (supine and bilateral decubital) from time to time for 30 minutes. The chest tube was clamped for 48 h and then the tube was declamped and allowed to drain. When the drainage effusion was less than 100 ml a day, the chest tube was removed. Any patient whose drainage effusion continued for over 2 weeks was withdrawn from the trial and was also judged to be a nonresponder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisplatin | Experimental | Drug: cisplatin75 mg of body surface area of ciplatin in distilled water is injected in to the chest through a chesttube. |
| Control | No intervention | –No intervention was applied. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cytologically proven and previously untreated malignant pleural effusion of Non-small-cell Lung Cancer;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1;
- A leucocyte count of≥4000µl;
- A platelet count of≥100000µl;
- A normal creatinine level;
Key exclusion criteria (5 listed)
- Previously treated malignant pleural effusion;
- Pericardial effusion；
- Pregnant；
- Uncontrolled hypertension or diabetes；
- Liver cihrosis.
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 |
|---|---|---|
| cisplatinAlso: cisplatinumciplatin in distilled water is injected into the chest for 48 h. | Drug | Cisplatin |
Primary outcome
overall response rate
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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.
Hongbiao Wang, Master principal investigator
Affiliated Cancer Hospital of Shantou University Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cisplatin in people with Pleural Effusion, Malignant, run by Shantou University Medical College 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 7 inclusion and 5 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 20 Nov 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.
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 Hongbiao Wang, Master (8613592882093, wanghongbiao123@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: one month). 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 20 Nov 2015.