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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-UMIN000008158 |
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Date of registration:
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01/07/2012 |
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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 II Study of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer (OSAKA-LCSG1202)
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Scientific title:
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A phase II Study of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer (OSAKA-LCSG1202) - A phase II Study of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer (OSAKA-LCSG1202) |
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Date of first enrolment:
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2012/07/01 |
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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=R000009603 |
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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 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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Takashi Kijima |
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Address:
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2-15 Yamada-oka, Suita, Osaka, Japan
Japan |
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Telephone:
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06-6879-3833 |
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Email:
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tkijima@imed3.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Hospital Dept. of Respiratory Medicine |
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Name:
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Takashi Kijima |
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Address:
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2-15 Yamada-oka, Suita, Osaka, Japan
Japan |
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Telephone:
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06-6879-3833 |
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Email:
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tkijima@imed3.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Hospital Dept. of Respiratory Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1.Adjuvant chemotherapy 2.Pneumonia or Pulmonary fibrosis detectable on chest X-rays. History of drug induced interstitial pneumonia. 3.History of severe drug allergy 4.Active synchronous malignancies 5.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 6.Severe complication 7.Metastasis to CNS 8.Patients with chest radiation treatment is required to reach the lung irradiation 9.Treated by flucytosine (5-FC) 10.Symptomatic brain metastasis 11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
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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Previously treated non-small cell lung cancer
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Intervention(s)
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Bevacizumab 15mg/kg (day1, 22) + S-1 80mg/m2 (day1~14) q3weeks until disease progression
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Primary Outcome(s)
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Response rate
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Secondary Outcome(s)
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Progression-free survival, Overall survival, Frequency and grade of adverse event
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Source(s) of Monetary Support
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Dept. of Respiratory Medicine, Osaka University Hospital
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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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30/06/2016 |
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URL:
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