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

NCT ID: NCT03394105

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-26
• Study Completion Date: 2018-06-22

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.

Conditions

Pleural Effusion, Malignant; Non-small Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intrapleural docetaxel administration

Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer.

Group Type: EXPERIMENTAL

intrapleural docetaxel administration

Intervention Type: DRUG

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

Interventions

intrapleural docetaxel administration

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

Intervention Type: DRUG

Other Intervention Names

Pleurodesis_docetaxel

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Chang-Min Choi

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

CHANG-MIN CHOI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

C2015-00353_Pleurodesis

Identifier Type: -

Identifier Source: org_study_id