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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02407912

Enrollment

Registered

2015-04-03

Start date

2015-03-31

Completion date

2020-03-31

Last updated

2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural Effusion, Malignant

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 Any patient whose drainage effusion continued for over 2 weeks was withdrawn from the trial and was also judged to be a nonresponder.

Interventions

DRUGcisplatin

ciplatin in distilled water is injected into the chest for 48 h.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
overall response rate	one month

Countries

China

Contacts

Primary ContactHongbiao Wang, Master

wanghongbiao123@qq.com8613592882093

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026