Non-small Cell Carcinoma, Pleural Effusion, Malignant
Conditions
Keywords
Pleurodesis
Brief summary
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.
Interventions
DRUGintrapleural docetaxel administration
intrapleural docetaxel administration using medical pleuroscopy in malignant effusion with lung cancer
Sponsors
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall respose rate(ORR) | through study completion (2.5 years) | Rate of CR and PR |
| Complete resonse (CR) rate | through study completion (2.5 years) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression(TTP) | through study completion (2.5 years) | time from the date of the start of treatment until the disease progression or death. |
| Overall survival(OS) | through study completion (2.5 years) | time fromthe date of the start of treatment to death or the date of last follow-up |
| Adverse Event | through study completion (2.5 years) | Based on National Cancer Institute Common Toxicity Criteria |
Countries
South Korea
Outcome results
None listed