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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-UMIN000017487 |
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Date of registration:
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22/05/2015 |
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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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A phase III study comparing nab-paclitaxel with docetaxel in patients with previously treated advanced non-small-cell lung cancer
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Scientific title:
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A phase III study comparing nab-paclitaxel with docetaxel in patients with previously treated advanced non-small-cell lung cancer - nab-PTX vs DTX Phase III |
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Date of first enrolment:
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2015/05/22 |
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Target sample size:
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500 |
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Recruitment status: |
Complete: follow-up continuing |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020268 |
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Study type:
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Interventional |
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Study design:
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Parallel 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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Yasuto Yoneshima |
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Address:
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3-1-1 Maidashi, Higashiku, Fukuoka 812-8582, Japan
Japan |
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Telephone:
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092-642-5378 |
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Email:
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y.yoneshima@gmail.com |
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Affiliation:
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Kyushu University Hospital Department of Respiratory Disease |
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Name:
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Isamu Okamoto |
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Address:
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3-1-1 Maidashi, Higashiku, Fukuoka 812-8582, Japan
Japan |
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Telephone:
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092-642-5378 |
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Email:
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okamotoi@kokyu.med.kyushu-u.ac.jp |
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Affiliation:
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Kyushu University Hospital Center for Clinical and Translational Research |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Treatment history of taxanes 2) Synchronous or metachronous active double malignancies 3) Infectious disease requiring systemic treatment 4) Fever of 38 degrees centigrade or higher 5) Psychotic disorder
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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Non-small cell lung cancer
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Intervention(s)
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A: Docetaxel (60 mg/m2) given on day 1 every 3 weeks
B: Nab-paclitaxel (100mg/m2) given on day 1,8,15 every 3 weeks
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Primary Outcome(s)
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Overall survival
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Secondary Outcome(s)
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Progression-free survival, response rate, toxicity, QOL
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Source(s) of Monetary Support
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TAIHO PHARMACEUTICAL CO., LTD.
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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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