Status:
COMPLETED
Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer
Lead Sponsor:
Asan Medical Center
Conditions:
Pleural Effusion, Malignant
Non-small Cell Carcinoma
Eligibility:
All Genders
20-79 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 26 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2018
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03394105
Start Date
July 26 2016
End Date
June 22 2018
Last Update
March 8 2019
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea