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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03394105
Other study ID # C2015-00353_Pleurodesis
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 26, 2016
Est. completion date June 22, 2018

Study information

Verified date March 2019
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date June 22, 2018
Est. primary completion date June 22, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 79 Years
Eligibility 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

Study Design


Intervention

Drug:
intrapleural docetaxel administration
intrapleural docetaxel administration using medical pleuroscopy in malignant effusion with lung cancer

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall respose rate(ORR) Rate of CR and PR through study completion (2.5 years)
Primary Complete resonse (CR) rate through study completion (2.5 years)
Secondary 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)
Secondary 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)
Secondary Adverse Event Based on National Cancer Institute Common Toxicity Criteria through study completion (2.5 years)
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