Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer

Study Overview
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Brief Summary
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In this trial, the effect of intrapleural docetaxel administration using medical pleuroscopywill be evaluated in Lung Cancer patient with malignant effusion.

Detailed Description
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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.

Official Title
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Pilot Study to Evaluate the Effect of Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer

Conditions
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Pleural Effusion, Malignant, Non-small Cell Carcinoma

Intervention / Treatment
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* Drug: intrapleural docetaxel administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intrapleural docetaxel administration<br>Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer. | Drug: intrapleural docetaxel administration<br>* intrapleural docetaxel administration using medical pleuroscopy in malignant effusion with lung cancer<br>* Other names: Pleurodesis_docetaxel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall respose rate(ORR) | Rate of CR and PR | through study completion (2.5 years) | 
| Complete resonse (CR) rate |  | through study completion (2.5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression(TTP) | time from the date of the start of treatment until the disease progression or death. | 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 | through study completion (2.5 years) | 
| Adverse Event | Based on National Cancer Institute Common Toxicity Criteria | through study completion (2.5 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pleurodesis