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

Not Applicable

• Conditions: Pleural Effusion, Malignant
• Interventions: Drug: cisplatin

• Registration Number: NCT02407912
• Lead Sponsor: 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.

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 Any patient whose drainage effusion continued for over 2 weeks was withdrawn from the trial and was also judged to be a nonresponder.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-18
• Last Update Posted: 2015-11-20
• Primary Completion: 2018-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cisplatin	cisplatin	75 mg of body surface area of ciplatin in distilled water is injected in to the chest through a chesttube.

Primary Outcome Measures

Name	Time	Method
overall response rate	one month

Trial Locations

Locations (1)

Department of medical oncology; 🇨🇳 Shantou, Guangdong, China