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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-UMIN000024330 |
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Date of registration:
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07/10/2016 |
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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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A phase II study of combination chemotherapy of oral tegafur/uracil, leucovorin and bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer
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Scientific title:
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A phase II study of combination chemotherapy of oral tegafur/uracil, leucovorin and bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer - A phase II study of UFT/LV and bevacizumab treatment |
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Date of first enrolment:
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2016/09/26 |
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Target sample size:
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35 |
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Recruitment status: |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027804 |
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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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Kiyoshi Maeda |
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Address:
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Asahimachi, Abeno-ku, Osaka
Japan |
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Telephone:
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06-6645-3838 |
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Email:
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m1378386@med.osaka-cu.ac.jp |
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Affiliation:
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Osaka City University Graduate School of Medicine Dept of Surgical Oncology |
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Name:
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Kiyoshi Maeda |
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Address:
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Asahimachi, Abeno-ku, Osaka
Japan |
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Telephone:
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06-6645-3838 |
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Email:
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m1378386@med.osaka-cu.ac.jp |
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Affiliation:
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Osaka City University Graduate School of Medicine Dept of Surgical Oncology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1)Patients with a past history of severe drug allergy 2)no other co-existing malignancy or malignancy within the last five years prior to enrollment other than non-melanoma skin cancer or in situ carcinoma of the cervix 3)patients were pregnant or lactating 4)Patients with psychiatric illness 5)Patients with severe co-morbidities (renal failure, liver dysfunction, uncontrolable diabetes mellitus and hypertension, heart failure) 6)Patients with massive ascites or hydrothorax 7)Patients with a symptomatic brain metastasis 8)Patients with abdominal surgery within 28days 9)Patients with perforated disease 10)Patients with thrombosis 11)Patiens with 3+ proteinurea
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 metastatic/recurrent colorectal cancer
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Intervention(s)
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UFT(300mg/m2/day) and LV(75mg/day) are simultaneously given 3times per day for 5days, followed by 2-day rest. Bevacizumab is administerd by every 3 weeks.
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Primary Outcome(s)
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Progression free survival
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Secondary Outcome(s)
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Overall survival, Time to treatment failure, Overall response rate, Disease control rate, Adverese
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Source(s) of Monetary Support
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Dept of Surgical Oncology Osaka City University Graduate School of Medicine
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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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