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Intrapleural hypotonic cisplatin treatment for malignant pleural effusion in non-small cell lung cancer patients with intestinal lung disease. A multicenter non randomized trial.

Intrapleural hypotonic cisplatin treatment for malignant pleural effusion in non-small cell lung cancer patients with intestinal lung disease. A multicenter non randomized trial. - NHOK-HypoCis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023102
Enrollment
35
Registered
2016-07-15
Start date
2016-07-15
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Interstitial pneumonia merger stage IV non-small cell lung cancer case with the malignant pleural effusion

Interventions

Sponsors

National Hospital Organization Kinki -Chuo Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) cytologically or histologically proven non-small cell lung cancer 2) cytologically or histologically proven malignant pleural effusion ,which had been untreated 3) Non-treatment case for non-small cell lung cancer or systemic treatment had been administered at least 31 days more before entry 4) dyspnea prior to chest tube drainage 5)a full expansion of lung obtained by chest tube drainage 6) Eligible patients were aged between 20 and 80 years 7) Eastern Cooperative Oncology Group(ECOG)PS 0-2 8) intestinal lung disease examined by computed tomography.(Intestinal lung diseases involve IPF,NSIP,DIP,RB-ILD, collagen vascular disease with intestinal lung disease and asbestosis related intestinal lung disease. AIP and COP were excluded) 9)life expectancy >= 30days 10)Written informed consent were obtained from the patient 11)14 days before entry, the following laboratory values were required: a leukocyte count>= 3000mm^3 a platelet count >= 100000mm^3 alanine aminotransferase < 100IU/l asparate aminotransferase< 100IU/l a serum creatinine level<= 1.5mg/dl

Exclusion criteria

Exclusion criteria: Exclusion criteria were as follows 1) All 1-3 were found within 30 days or possibility of acute exacerbation of intestinal lung disease. 1. worsening of respiratory distress 2. emerging ground grass attenuation or consolidation of the lung by computed tomography 3. worsening of PaO2 >= 10Torr 2) lung cancer had not been treated within 30 days 3) active double cancer 4) allergic reaction for lidocaine 5) carcinomatous pericarditis 6) uncontrolled heart failure 7) myocardial infarction within 30days 8) unstable angina pectoris 9) active infectious diseases 10) drug allery>= Grade3 11) Pregnancy, lactating woman, women of childbearing potential and patients not intend to prevent pregnancy 12) allergic pulmonary disorders or acute exacerbation of intestinal lung diseases 13) surgical treatment had previously been done for thorax in the malignant effusion 14) steroid usage (predonine >= 5mg) 15) SpO2 <90(under room air) 16) physician assessed that patients are not adequate for this study

Design outcomes

Primary

MeasureTime frame
The pleural effusion control rate (30days after administration of hypotonic cisplatin for malignant pleural effusion)

Secondary

MeasureTime frame
Proportion of acute exacerbation of intestinal lung disease,overall survival, pleural effusion free progression free survival, Toxicities

Countries

Japan

Contacts

Public ContactTakehiko Kobayashi

National Hospital Organization Kinki -Chuo Medical Center Medicine in general

t-kobayashi@kch.hosp.go.jp072-252-3021

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026