MedDataX Logo

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

NCT ID: NCT02407912

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2020-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 Any patient whose drainage effusion continued for over 2 weeks was withdrawn from the trial and was also judged to be a nonresponder.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pleural Effusion, Malignant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cisplatin

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

Group Type EXPERIMENTAL

cisplatin

Intervention Type DRUG

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

Control

No intervention was applied.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cisplatin

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

cisplatinum

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shantou University Medical College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hongbiao Wang

Associate chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hongbiao Wang, Master

Role: PRINCIPAL_INVESTIGATOR

Affiliated Cancer Hospital of Shantou University Medical College

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of medical oncology

Shantou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hongbiao Wang, Master

Role: CONTACT

[email protected]
8613592882093

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hongbiao Wang, Master

Role: primary

[email protected]
8613592882093

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LXY 01

Identifier Type: -

Identifier Source: org_study_id