UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intrapleural hypotonic cisplatin treatment for malignant pleural effusion in non-small cell lung cancer patients with intestinal lung disease. A multicenter non randomized trial.
Title of the study (Brief title)	NHOK-HypoCis
Region	Japan

Condition
Condition	Interstitial pneumonia merger stage IV non-small cell lung cancer case with the malignant pleural effusion
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of hypotonic cisplatin treatment for malignant pleural effusion in non-small cell lung cancer patients with intestinal lung disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The pleural effusion control rate (30days after administration of hypotonic cisplatin for malignant pleural effusion)
Key secondary outcomes	Proportion of acute exacerbation of intestinal lung disease,overall survival, pleural effusion free progression free survival, Toxicities

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Multicenter, single-arm, open-label trial
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key 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
Key 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
Target sample size	35

Research contact person
Name of lead principal investigator	Naoki Omachi
Organization	National Hospital Organization Kinki -Chuo Medical Center
Division name	clinical oncology
Address	1180, Nagasonecho, Kita-ku, Sakai-shi, Osaka
TEL	072-252-3021
Email	nomachi@kch.hosp.go.jp

Public contact
Name of contact person	Takehiko Kobayashi
Organization	National Hospital Organization Kinki -Chuo Medical Center
Division name	Medicine in general
Address	1180, Nagasonecho, Kita-ku, Sakai-shi, Osaka
TEL	072-252-3021
Homepage URL
Email	t-kobayashi@kch.hosp.go.jp

Sponsor
Institute	National Hospital Organization Kinki -Chuo Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 20 Day
Anticipated trial start date	2016 Year 07 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 11 Day
Last modified on	2017 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026319