UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006491 |
|---|---|
| Receipt number | R000007702 |
| Scientific Title | Prospective feasible study for the postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis |
| Date of disclosure of the study information | 2011/10/06 |
| Last modified on | 2012/04/19 14:12:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective feasible study for the postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis
Acronym
Prospective feasible study of postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis
Scientific Title
Prospective feasible study for the postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis
Scientific Title:Acronym
Prospective feasible 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 feasiblity 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,II
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 300,000 unit 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
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yotaro Izumi |
Organization
Keio University School of Medicine
Division name
Division of General Thoracic Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
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
Sponsor or person
Institute
Keio University School of Medicine, division of General Thoracic Surgery
Institute
Department
Personal name
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
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
| 2011 | Year | 10 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | 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
| 2011 | Year | 10 | Month | 06 | Day |
Last modified on
| 2012 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007702
