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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002410
Receipt No. R000002929
Scientific Title Phase I study for the safty of the postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis
Date of disclosure of the study information 2009/08/31
Last modified on 2012/08/31

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Basic information
Public title Phase I study for the safty of the postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis
Acronym Phase I study of postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis
Scientific Title Phase I study for the safty of the postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis
Scientific Title:Acronym Phase I study of postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis
Region
Japan

Condition
Condition interstitial pneumonitis
lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We are going to analyze the safety and efficacy og postoperative ulinastatin therapy on patients with resectable lung cancer comorbid with interstitial pneumonitis for the prevention of acute exacerbation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Until 1POM, we are going to judge clinically whether adverse outcomes happen, which is thought to be side-effects caused by postoperative ulinastatin therapy.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 After the operation, intravenous infusion of designed amount of urinastatin is administered 9 times in every 8 hours.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed lung cancer
2) cStage IA-IIIB, resectable
3) lung resection is planned
4) the case diagnosed as lung cancer with interstitial pneumonitis by one clinical radiologist in our hospital. The standard of diagnose is below.
1.coin lesion just under the pleura
2.honeycomb lung
3.tractional bronchitis, bronchioles ectasia
4.ground grass opacity
5.consolidation
5)performance status of 0 to 1
6)Adequate hematologic, hepatic, renal, and cardiac function diagnosed within 2 weeks before the registration.
*WBC >=3,000/mm3 - <=12,000/mm3
*Absolute neutrophil count 1,500/mm3 - 5000/mm3
*Platelet count >=75,000/mm3
*Hemoglobin >=8.0g/dL
*AST and ALT 2.5 times upper limit of normal
*Total bilirubin <1.5mg/dL
*Creatinine 1.5 times upper limit of normal
*ECG normal
*SpO2 90% (room air)
7) general anesthesia is permitted
8) Written informed consent
Key exclusion criteria a)asbestosis
b)Patients with interstitial pneumonitis caused by connective tissue disease
c)chronic hypersensitivity pneumonitis
d)sarcoidosis
e)Patients who have the history of allergic reactions against urinastatin
f)Patients who are pregnant or have possibility of pregnancy
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Izumi Yotaro
Organization Keio University School of Medicine
Division name Division of General Thoracic Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University School of Medicine
Division name Division of General Thoracic Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Keio University School of Medicine, division of General Thoracic Surgery
Institute
Department

Funding Source
Organization Keio University School of Medicine, division of General Thoracic Surgery
Organization
Division
Category of Funding Organization Self funding
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 慶應義塾大学病院

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/22216165
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 Completed
Date of protocol fixation
2009 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2012 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 31 Day
Last modified on
2012 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002929

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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