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Completed

NCT Number: NCT03394105

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

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

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Key information

Conditions

Pleural Effusion, Malignant Neoplasms Neoplasms by Site Non-small Cell Carcinoma Pleural Diseases Pleural Effusion Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asan Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intrapleural docetaxel administration

Drug

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

Other names: Pleurodesis_docetaxel

Primary outcomes

  1. Overall respose rate(ORR)

    Time frame: through study completion (2.5 years)

    Rate of CR and PR

  2. Complete resonse (CR) rate

    Time frame: through study completion (2.5 years)

Secondary outcomes

  1. Time to progression(TTP)

    Time frame: through study completion (2.5 years)

    time from the date of the start of treatment until the disease progression or death.

  2. Overall survival(OS)

    Time frame: through study completion (2.5 years)

    time fromthe date of the start of treatment to death or the date of last follow-up

  3. Adverse Event

    Time frame: through study completion (2.5 years)

    Based on National Cancer Institute Common Toxicity Criteria

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Pilot Study to Evaluate the Effect of Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 9, 2018
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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