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

NCT03394105 | Completed Phase 2

• 1 other identifier: C2015-00353_Pleurodesis
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pleural Effusion, Malignant; Non-small Cell Carcinoma

Keywords

Pleurodesis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Time to progression(TTP)

  through study completion (2.5 years)

• Overall survival(OS)

  through study completion (2.5 years)

• Adverse Event

  through study completion (2.5 years)

Study Arms (1)

intrapleural docetaxel administration

EXPERIMENTAL

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

Drug: intrapleural docetaxel administration

Interventions

intrapleural docetaxel administration DRUG

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

Also known as: Pleurodesis_docetaxel

intrapleural docetaxel administration

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• CHANG-MIN CHOI, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: January 9, 2018
• Study Start: July 26, 2016
• Primary Completion: June 22, 2018
• Study Completion: June 22, 2018
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

KR (1)