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

Primary Purpose

Pleural Effusion, Malignant

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cisplatin
Sponsored by
Shantou University Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion, Malignant

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of medical oncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cisplatin

Control

Arm Description

75 mg of body surface area of ciplatin in distilled water is injected in to the chest through a chesttube.

No intervention was applied.

Outcomes

Primary Outcome Measures

overall response rate

Secondary Outcome Measures

Full Information

First Posted
March 31, 2015
Last Updated
November 18, 2015
Sponsor
Shantou University Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT02407912
Brief Title
Cisplatin for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer
Official Title
Intrapleural Hypertonic Cisplatin Treatment for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shantou University Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion, Malignant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cisplatin
Arm Type
Experimental
Arm Description
75 mg of body surface area of ciplatin in distilled water is injected in to the chest through a chesttube.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention was applied.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
cisplatinum
Intervention Description
ciplatin in distilled water is injected into the chest for 48 h.
Primary Outcome Measure Information:
Title
overall response rate
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongbiao Wang, Master
Phone
8613592882093
Email
wanghongbiao123@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongbiao Wang, Master
Organizational Affiliation
Affiliated Cancer Hospital of Shantou University Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of medical oncology
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongbiao Wang, Master
Phone
8613592882093
Email
wanghongbiao123@qq.com

12. IPD Sharing Statement

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

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