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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-UMIN000018322 |
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Date of registration:
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15/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia
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Scientific title:
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Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia - Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia |
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Date of first enrolment:
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2012/12/01 |
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Target sample size:
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35 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021197 |
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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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Kojiro Otsuka |
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Address:
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2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan 650-0047
Japan |
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Telephone:
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078-302-4321 |
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Email:
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kotsuka@kcho.jp |
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Affiliation:
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Kobe City Medical Center General Hospital Department of Respiratory Medicine |
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Name:
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Nobuyuki Katakami |
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Address:
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2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan 650-0047
Japan |
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Telephone:
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078-302-4321 |
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Email:
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nkatakami@kcho.jp |
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Affiliation:
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Kobe City Medical Center General Hospital Department of Medical Oncology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Secondary interstitial pneumonia. 2) History of acute exacerbation of interstitial pneumonia within 3 months. 3) Subacute progression of interstitial pneumonia within 3 months. 4) Using prednisolone or immune-suppressive agent. 5) In need of home oxygen therapy. 6) Past history of severe drug allergy. 7) Active infectious disease. 8) Severe complications 9) brain metastasis. 10) Uncontrollable effusion. 11) history of hemosputum 12) tumor invasion into thoracic large vessels or tumor with cavity 13)active gastrointestinal ulcer 14)bleeding tendency 15)operation wound not cured 16)thrombosis in need with treatment 17) Active combined malignancy 18) Any ineligible case judged by physician.
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-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia
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Intervention(s)
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carboplatin AUC = 5, day1 paclitaxel 70mg/m2, day1 ,8 ,15 bevacizumab 15mg/kg, day1 every 4 weeks, 4-6 cycle
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Primary Outcome(s)
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response rate
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Secondary Outcome(s)
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OS: overall survival PFS: progression free survival TTF: time to treatment failure toxicity
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Source(s) of Monetary Support
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none
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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