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

Pleural Effusion, Malignant Clinical Trial

Official title:

Intrapleural Hypertonic Cisplatin Treatment for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02407912
• Other study ID #: LXY 01
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2015
• Last updated: November 18, 2015
• Start date: March 2015
• Est. completion date: March 2020

Study information

• Verified date: November 2015
• Source: Shantou University Medical College
• Contact: Hongbiao Wang, Master
• Phone: 8613592882093
• Email: wanghongbiao123[@]qq.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 Any patient whose drainage effusion continued for over 2 weeks was withdrawn from the trial and was also judged to be a nonresponder.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2020
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Drug:
• cisplatin
ciplatin in distilled water is injected into the chest for 48 h.

Locations

Country	Name	City	State
China	Department of medical oncology	Shantou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shantou University Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate		one month	Yes