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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-UMIN000030999 |
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Date of registration:
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26/01/2018 |
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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 I and II study of S-1+vinorelbine in patients with advanced non-small cell cancer
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Scientific title:
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Phase I and II study of S-1+vinorelbine in patients with advanced non-small cell cancer - Phase I and II study of S-1+vinorelbine in patients with advanced non-small cell cancer |
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Date of first enrolment:
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2007/08/01 |
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Target sample size:
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35 |
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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=R000035386 |
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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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Phase I,II
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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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Eiji Shimizu |
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Address:
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86 Nichi-machi, Yonago, Tottori Japan
Japan |
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Telephone:
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0859-38-6537 |
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Email:
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eiji@med.tottori-u.ac.jp |
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Affiliation:
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Faculty of Medicine, Tottori University Division of Medical Oncology and Molecular Respirology |
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Name:
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Tadashi Igishi |
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Address:
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86 Nichi-machi, Yonago, Tottori Japan
Japan |
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Telephone:
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0859-38-6537 |
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Email:
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igishi@med.tottori-u.ac.jp |
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Affiliation:
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Faculty of Medicine, Tottori University Division of Medical Oncology and Molecular Respirology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Patient with need of procedure for pleural effusion 2. Patient with need of drainage procedure for cardiac effusion 3. Patient with symptomatic brain metastasis 4. Patient with severe complications 5. Patient with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X-ray 6. Female patient in or having achance or planning of pregnancy or breast feeding 7. Male patient in plannning to impregnate 8. Patient with active multiple cancers 9. Patient with history of drug hypersensitivity 10. Patient with history of hypersensitivity against vinorelbine or other vinca alkaloids 11. Patient with history of hypersensitivity against TS-1 or pyrimidine fluoride 12. Being treated with other pyrimidine fluoride 13. Being treated with flucytosine 14. Any patient judged by the investigator to be unfit to participate in the 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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unresectable non-small cell lung cancer
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Intervention(s)
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To determine recommended dose of S-1 and vinorelbine in phase I study, and to evaluate safety and efficacy of the combination of vinorelbine and S-a in patients with advanced non-small cell lung cancer
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Primary Outcome(s)
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Phase I study: recommended dose Phase II study: progression free survival
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Secondary Outcome(s)
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Disease control rate, Overall survival, Response rate, Safety
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Source(s) of Monetary Support
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Self funding
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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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Yes |
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Date Posted:
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Date Completed:
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03/06/2013 |
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URL:
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