NCT02407912

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

3 years

First QC Date

March 31, 2015

Last Update Submit

November 18, 2015

Conditions

Pleural Effusion, Malignant

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    one month

Study Arms (2)

Cisplatin

EXPERIMENTAL

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

Drug: cisplatin

Control

NO INTERVENTION

No intervention was applied.

Interventions

cisplatinDRUG

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

Also known as: cisplatinum
Cisplatin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of medical oncology

Shantou, Guangdong, 515031, China

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Hongbiao Wang, Master

    Affiliated Cancer Hospital of Shantou University Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongbiao Wang, Master

CONTACT

8613592882093wanghongbiao123@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 3, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2020

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

CN(1)