Unique ID issued by UMIN | UMIN000010259 |
---|---|
Receipt number | R000012008 |
Scientific Title | A Phase II Study of Bi-weekly XELOX with Bevacizumab for patient with Metastatic Colorectal Cancer as first-line chemotherapy |
Date of disclosure of the study information | 2013/03/17 |
Last modified on | 2022/03/28 08:22:30 |
A Phase II Study of Bi-weekly XELOX with Bevacizumab for patient with Metastatic Colorectal Cancer as first-line chemotherapy
Bi-weekly XELOX with Bevacizumab
A Phase II Study of Bi-weekly XELOX with Bevacizumab for patient with Metastatic Colorectal Cancer as first-line chemotherapy
Bi-weekly XELOX with Bevacizumab
Japan |
advanced and/or recurrent colorectal cancer
Medicine in general | Gastroenterology | Surgery in general |
Malignancy
YES
To evaluate the efficacy and safety of bi-weekly XELIRI plus bevacizumab in advanced colorectal cancer as first-line chemotherapy
Safety,Efficacy
Exploratory
Pragmatic
Phase II
progression free survival
overall survival
Time to Treatment Failur
Response Rate
Disease Control Rate
Relative Dose Intensity
Rate of Adverse Event
safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
XELIRI plus bevacizumab therapy
/Capecitabine;2,000 mg/m2 day1-8(orally, day1 after dinner; day8 after breakfast)
/Oxaliplatin 85 mg/m2 day1
/Bevacizumab: 5mg/kg day 1
The treatment is repeated every two weeks until disease progression or severe toxicity
20 | years-old | <= |
Not applicable |
Male and Female
(1) Written informed consent after the explanation of the content of the examination
(2) Age of 20 years or older
(3) ECOG PS 0-1
(4) Life expectancy more than 3 months
(5) Histopathologically confirmed colorectal cancer
(6) Measurable or evaluable disease (RECIST ver.1.1)
(7) Metastatic colorectal cancer which has non prior therapy
(8)Adequate organ functions
(1) Severe renal function disorder
(2) History of serious drug hypersensitivity or a history of drug allergy
(3) History of active double cancer within 5 years
(4) Active infections
(5) Distinctly abnormal ECG or cardiovascular disease
(6) Cpmplication of thromboembolism,severe pulmonary disease(interstitial pneumonia, pulmonary fibrosis, mild Emphysema)
"(7) complication of GI perforation or hemorrhage ,Paresis of intestine or intestinal obstruction
"
(8) Massive pleural effusion or ascites that required drainage
(9) Brain metastasis
(10) Complication of mental disorder,CNS disease, cerebrovascular disease.
(11) Uncontrollable hypertension or diabetes mellitus
(12) Uncontrollable diarrhea
"(13) Patients with non-healing wounds,or surgery (thoracotomy, laparotomy) within 4 weeks
"
(14) Non-healing fracture
(15) Bleeding diathesis or receiving anticoagulant drug(except Aspirin under 325mg/day)
(16) Pregnant or lactating woman
(17) Peripheral neuropathy
(18) Other conditions not suitable for this study
45
1st name | Shoichi |
Middle name | |
Last name | Hazama |
Yamaguchi University Graduate School of Medicibe
Digestive surgery and surgical oncology
755-8505
1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
+81-836-22-2264
hazama@yamaguchi-u.ac.jp
1st name | Shoichi |
Middle name | |
Last name | Hazama |
Yamaguchi University Graduate School of Medicibe
Digestive surgery and surgical oncology
755-8505
1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
+81-836-22-2264
hazama@yamaguchi-u.ac.jp
Yamaguchi University Graduate School of Medicibe, Digestive surgery and surgical oncology
Yamaguchi University Graduate School of Medicibe, Digestive surgery and surgical oncology
Self funding
Yamaguchi University
1-1-1 Minami-Kogushi
0836222428
me223@yamaguchi-u.ac.jp
NO
2013 | Year | 03 | Month | 17 | Day |
Unpublished
Terminated
2013 | Year | 03 | Month | 17 | Day |
2012 | Year | 12 | Month | 25 | Day |
2013 | Year | 03 | Month | 18 | Day |
2022 | Year | 03 | Month | 31 | Day |
2013 | Year | 03 | Month | 17 | Day |
2022 | Year | 03 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012008