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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023102
Receipt No. R000026319
Scientific Title Intrapleural hypotonic cisplatin treatment for malignant pleural effusion in non-small cell lung cancer patients with intestinal lung disease. A multicenter non randomized trial.
Date of disclosure of the study information 2016/07/15
Last modified on 2017/05/17

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Basic information
Public title Intrapleural hypotonic cisplatin treatment for malignant pleural effusion in non-small cell lung cancer patients with intestinal lung disease. A multicenter non randomized trial.
Acronym NHOK-HypoCis
Scientific Title Intrapleural hypotonic cisplatin treatment for malignant pleural effusion in non-small cell lung cancer patients with intestinal lung disease. A multicenter non randomized trial.
Scientific Title:Acronym 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
1st name
Middle name
Last name Naoki Omachi
Organization National Hospital Organization Kinki -Chuo Medical Center
Division name clinical oncology
Zip code
Address 1180, Nagasonecho, Kita-ku, Sakai-shi, Osaka
TEL 072-252-3021
Email nomachi@kch.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takehiko Kobayashi
Organization National Hospital Organization Kinki -Chuo Medical Center
Division name Medicine in general
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 05 Month 20 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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