Unique ID issued by UMIN | UMIN000002410 |
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Receipt number | 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 15:58:05 |
Phase I study for the safty of the postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis
Phase I study of postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis
Phase I study for the safty of the postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis
Phase I study of postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis
Japan |
interstitial pneumonitis
lung cancer
Chest surgery |
Malignancy
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Phase I
Until 1POM, we are going to judge clinically whether adverse outcomes happen, which is thought to be side-effects caused by postoperative ulinastatin therapy.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Prevention
Medicine |
After the operation, intravenous infusion of designed amount of urinastatin is administered 9 times in every 8 hours.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
9
1st name | |
Middle name | |
Last name | Izumi Yotaro |
Keio University School of Medicine
Division of General Thoracic Surgery
35 Shinanomachi, Shinjuku-ku, Tokyo
1st name | |
Middle name | |
Last name |
Keio University School of Medicine
Division of General Thoracic Surgery
35 Shinanomachi, Shinjuku-ku, Tokyo
Keio University School of Medicine, division of General Thoracic Surgery
Keio University School of Medicine, division of General Thoracic Surgery
Self funding
NO
慶應義塾大学病院
2009 | Year | 08 | Month | 31 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/22216165
Completed
2009 | Year | 08 | Month | 19 | Day |
2009 | Year | 09 | Month | 01 | Day |
2012 | Year | 10 | Month | 01 | Day |
2009 | Year | 08 | Month | 31 | Day |
2012 | Year | 08 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002929
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