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Cisplatin for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02407912
Recruitment Status : Recruiting
First Posted : April 3, 2015
Last Update Posted : November 20, 2015
Information provided by (Responsible Party):
Hongbiao Wang, Shantou University Medical College

Brief Summary:
To assess the effect and toxicity of intrapleural administration of hypertonic cisplatin for malignant pleural effusion in patients with non-small-cell lung cancer.

Condition or disease Intervention/treatment Phase
Pleural Effusion, Malignant Drug: cisplatin Not Applicable

Detailed Description:
The lung was fully expanded by a thoracostomy using a chest tube with a double lumen, and then the patients were enrolled into the trial.First, premedication including antiemetics and hydration were performed. Thereafter, 75 mg of body surface area of cisplatin in 50 ml of distilled water was injected through a chest tube.The patients were asked to change position (supine and bilateral decubital) from time to time for 30 minutes. The chest tube was clamped for 48 h and then the tube was declamped and allowed to drain. When the drainage effusion was less than 100 ml a day, the chest tube was removed. Any patient whose drainage effusion continued for over 2 weeks was withdrawn from the trial and was also judged to be a nonresponder.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intrapleural Hypertonic Cisplatin Treatment for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer.
Study Start Date : March 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: Cisplatin
75 mg of body surface area of ciplatin in distilled water is injected in to the chest through a chesttube.
Drug: cisplatin
ciplatin in distilled water is injected into the chest for 48 h.
Other Name: cisplatinum

No Intervention: Control
No intervention was applied.

Primary Outcome Measures :
  1. overall response rate [ Time Frame: one month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cytologically proven and previously untreated malignant pleural effusion of Non-small-cell Lung Cancer;
  • An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1;
  • A leucocyte count of≥4000µl;
  • A platelet count of≥100000µl;
  • A normal creatinine level;
  • Serum glutamic oxaloacetic transaminase/glutamic pyruvic transaminase levels of no more than twice the upper limit of normal;
  • Survival time ≥12 weeks.

Exclusion Criteria:

  • Previously treated malignant pleural effusion;
  • Pericardial effusion;
  • Pregnant;
  • Uncontrolled hypertension or diabetes;
  • Liver cihrosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02407912

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Contact: Hongbiao Wang, Master 8613592882093

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China, Guangdong
Department of medical oncology Recruiting
Shantou, Guangdong, China, 515031
Contact: Hongbiao Wang, Master    8613592882093   
Sponsors and Collaborators
Shantou University Medical College
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Principal Investigator: Hongbiao Wang, Master Cancer Hospital of Shantou University

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Responsible Party: Hongbiao Wang, Associate chief physician, Shantou University Medical College Identifier: NCT02407912     History of Changes
Other Study ID Numbers: LXY 01
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Pleural Effusion
Pleural Effusion, Malignant
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pleural Diseases
Pleural Neoplasms
Antineoplastic Agents