Unique ID issued by UMIN | UMIN000003447 |
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Receipt number | R000004170 |
Scientific Title | Phase II study of chemotherapy with UFT/LV/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer. |
Date of disclosure of the study information | 2010/04/20 |
Last modified on | 2021/05/25 15:32:42 |
Phase II study of chemotherapy with UFT/LV/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer.
Phase II study of chemotherapy with UFT/LV/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer.
Phase II study of chemotherapy with UFT/LV/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer.
Phase II study of chemotherapy with UFT/LV/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer.
Japan |
advanced and recurrent colorectal cancer
Surgery in general | Gastrointestinal surgery |
Malignancy
NO
To evaluate the clinical effectiveness and toxicity of UFT/LV/Bevacizumab combination chemotherapy for elderly advanced and recurrent colorectal cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Overall response rate
Disease-free survival
Overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
UFT 300mg/m2/day and LV 50mg/body/day is administered orally for 21 days every 28 days.
Bevacizumab 5mg/kg is administered intravenous injection on day 1,15.
75 | years-old | <= |
Not applicable |
Male and Female
1)Patients with pathologically proven colorectal cancer(adenocarcinoma)
2)Patients with unrecectable advanced and recurrent colorectal cancer
3)Patients with confirmed target lesion
4)Patients with no prior chemotherapy
5)Patients with no prior radiotherapy
6)Patients of age =>75
7)Performance Status:0-2(ECOG)
8)Patients with not enforceable intensive chemotherapy
9)Patients with expected life for at 90 days
10)Sufficient organ functions
i. neutrophils>=1,500/mm3
ii. platelets>=100,000/mm3
iii. hemoglobin>=9.0g/dL
iv. total bilirubin<=1.5mg/dL
v. AST/ALT<=100IU(or <=150IU if liver metastases were present)
vi.serum creatinine<=1.5mg/dL
11)Capability of oral intake
12)Written informed consent
1)Medical history of severe anaphylazis or allergia to any drug
2)Active double cancer
3)Serious infection
4)Uncontrolled hypertention
5)Severe complication
6)Massive pleural or abdominal effusion
8)Brain metastasis
9)Severe mental illness
10)Systemic administration of corticosteroids
11)Uric protein 2+
12)Thrombosis , cerebral infraction , cardiac infraction , pulmonary infraction
13)Patients who underwent surgery within 4 weeks
14)Systemic administration of antiplatelet drug
15)Patients with known bleeding disorders or clotting disorder
16)Patients who are judged inappropriate for the entry into the study by the investigator
40
1st name | |
Middle name | |
Last name | Hiroshi Tamagawa |
Otemae Hospital
Department of Surgery
1-5-34 Otemae Chuou Osaka-city Osaka, Japan
06-6941-0484
hiroh2jr@hotmail.com
1st name | |
Middle name | |
Last name | Masataka Ikeda Tsunekazu Mizushima |
Osaka University Graduate School of Medicine
Department of Surgery
2-15 Yamadaoka Suita-city Osaka,Japan
06-6879-3251
tmizushima@gesurg.med.osaka-u.ac.jp
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
None
Self funding
NO
2010 | Year | 04 | Month | 20 | Day |
Published
http://www.karger.com/Article/Abstract/381718
Main results already published
2010 | Year | 03 | Month | 24 | Day |
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 04 | Month | 04 | Day |
2021 | Year | 05 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004170
Research Plan | |
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Registered date | File name |
2016/07/06 | 高齢者進行・再発大腸癌に対するUFTLV(分2)+Bevacizumab療法の第Ⅱ相臨床試験.zip |
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