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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000021591 |
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Date of registration:
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01/04/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia
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Scientific title:
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The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia - The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia |
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Date of first enrolment:
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2016/04/04 |
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Target sample size:
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30 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024894 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hisashi
Tanaka |
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Address:
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Zaifu-cho 5, Hirosaki, Japan
0368056
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Telephone:
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+81-172-33-5111 |
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Email:
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xyghx335@gmail.com |
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Affiliation:
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Hirosaki University Graduate School of Medicine Department of Respiratory Medicine |
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Name:
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sadatomo
Tasaka |
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Address:
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Zaifu-cho 5, Hirosaki, Japan
Japan |
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Telephone:
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0172395468 |
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Email:
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xyghx335@gmail.com |
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Affiliation:
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Hirosaki University Graduate School of Medicine Department of Respiratory Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1)Uncotrollable angiona pectorias, cardian infarction, haear failure, diabetes mellitus, hypertension 2) Using prednisolone >10mg/day 3) Active infection 4) Active double cancers 5) symptomatic brain metastasis 6) Patients with uncontrolled pleural or pericardial effusion, or ascites 7) pregnancy 8) Patient with a history of allergy to CBDCA, PTX and nintedanib 9) Inappropriate patients in this study
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Advanced non-small cell lung cancer with idiopathic interstitial pneumonia
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Intervention(s)
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carboplatin AUC6 D1 paclitaxel 200mg/m D1 tryweekly 4cycle nintedanib 150mg twice daily
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Primary Outcome(s)
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The frequency of treatment-related ILD
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Secondary Outcome(s)
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RR: response rate OS: overall survival PFS: progression free survival
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Source(s) of Monetary Support
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Hirosaki University Graduate School of Medicine
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Ethics review
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Status: YES
Approval date: 04/04/2016
Contact:
rinri@hirosaki-u.ac.jp
IRB of Hirosaki
0172335111
rinri@hirosaki-u.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/04/2021 |
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URL:
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