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

Shantou University Medical College

Status: Unknown

Conditions: Pleural Effusion, Malignant

Treatments: Drug: cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02407912

LXY 01

Details and patient eligibility

About

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

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 Any patient whose drainage effusion continued for over 2 weeks was withdrawn from the trial and was also judged to be a nonresponder.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Cisplatin

Experimental group

Description:

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

Treatment:

Drug: cisplatin

Control

No Intervention group

Description:

No intervention was applied.