Unique ID issued by UMIN | UMIN000003915 |
---|---|
Receipt number | R000004706 |
Scientific Title | Cohort study of XELOX in combination with bevacizumab for unresectable or recurrent colorectal cancer |
Date of disclosure of the study information | 2010/07/14 |
Last modified on | 2017/01/13 13:42:08 |
Cohort study of XELOX in combination with bevacizumab for unresectable or recurrent colorectal cancer
Cohort study of XELOX in combination with bevacizumab for unresectable or recurrent colorectal cancer(KSCC0902)
Cohort study of XELOX in combination with bevacizumab for unresectable or recurrent colorectal cancer
Cohort study of XELOX in combination with bevacizumab for unresectable or recurrent colorectal cancer(KSCC0902)
Japan |
Colorectal Cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and the safety of XELOX/Bevacitumab as a first line chemotherapy for the patients with unresectable or recurrent colorectal cancer
Safety,Efficacy
Pragmatic
Phase IV
Response rate
Progression free survival
Time to tretment failure
Time to failure of strategy
Overall survival
Safety
Quality of life
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Oxaliplatin 130mg/m2 i.v. (day1)
Bevaciumab 7.5mg/Kg i.v. (day1)
Capecitabine X2,000mg/m2, p.o.(day1-14)
to be repeated every 3 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1.Written informed consent
2.Appropriate for the study at the physician's assessment
3.Histologically confirmed adenocarcinoma of the colon or rectum.
4.No prior chemotherapy for the patients with unresectable or recurrent colorectal cancer
5.Prior adjuvant chemotherapy is allowed if it is completed at least 2 weeks before registration.
6.No prior radiotherapy for target lesion.
7.Aged 20<= years.
8.ECOG performance status of 0-2.
9.At least one measurable lesion based on the RECIST criterion. (within 28 days before registration)
10.Life expectancy at least 3 months.
11.Required baseline laboratory parameters (within 14 days before registration):
WBC more than 3000 and WBC less than 12000/mm3
Neu more than 1,500/ mm3
Plt more than 100,000/ mm3
Hb more than 9.0g/dl
T-Bil less than 2.0mg/dl
AST,ALT within 2.5 times of normal limit of each hospital(in case of hepatic metastatic patients are within 5.0 times of normal limit )
Cre less than 1.5mg/dl
Urinary protein less than grade1 (+1 or 0.15-1.0g/24h)
1.Co-mobility, such as infection, heart failure, history of cardiac infarction, liver cirrhosis, viral hepatitis type B , jaundice, kidney failure, uncontrolled hypertension, diabetes, interstitial lung disease, lung fibrosis, pulmonary emphysema.
2.Coelomic fluid which need therapy( pleural effusion, abdominal dropsy, pericardial fluid)
3.History of the severe hypersensitivity
4.Active other malignancies.
5.History of mental disorder, central nerve disorder, cerebral vascular disorder.
6.Brain metastasis
7.Evidence of bleeding diathesis, intestinal paralysis , ileus, peptic ulcer, traumatic bone fracture
8.Watery stools or Grade 2 or more diarrhea
9.Surgical procedure within 4 weeks before registration (implantation of the central venous port within 1 week before registration.)
10.Requiring anti-thrombogenic therapy to prevent thrombosis
11.Requiring immunosuppressive drug or steroid drug
12.Pregnant or lactating woman
13.Not appropriate for the study at the physician's assessment
41
1st name | |
Middle name | |
Last name | Kazuo Shirouzu |
Kurume University School of Medicine
Department of Surgery Medicine
67 Asahimachi, Kurume City, 830-0011, Japan
092-631-2920
kscc2@cres-kyushu.or.jp
1st name | |
Middle name | |
Last name | KSCC |
CLinical Research Support Center Kyushu
KSCC
3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan, 812-8582
092-631-2920
kscc2@cres-kyushu.or.jp
Kyushu Study group of Clinical Cancer
Clinical Research Support Center Kyushu
Non profit foundation
NO
九州大学(福岡県)
貝塚病院(福岡県)
国立病院機構九州医療センター(福岡県)
国立病院機構九州がんセンター(福岡県)
公立学校共済組合九州中央病院(福岡県)
済生会福岡総合病院(福岡県)
福岡歯科大学医科歯科総合病院(福岡県)
済生会八幡総合病院(福岡県)
新日鐵八幡記念病院(福岡県)
国立病院機構福岡東医療センター(福岡県)
社会保険田川病院(福岡県)
社会保険仲原病院(福岡県)
久留米大学(福岡県)
久留米大学医療センター(福岡県)
社会保険久留米第一病院(福岡県)
聖マリア病院(福岡県)
公立八女総合病院(福岡県)
飯塚病院(福岡県)
宗像医師会病院(福岡県)
福岡市民病院(福岡県)
新小文字病院(福岡県)
福岡大学(福岡県)
福岡大学筑紫病院(福岡県)
済生会唐津病院(佐賀県)
有田共立病院(佐賀県)
健康保険諫早総合病院(長崎県)
佐世保市立総合病院(長崎県)
白十字会 佐世保中央病院(長崎県)
長崎大学(長崎県)
春回会 井上病院(長崎県)
光晴会病院(長崎県)
医理会 柿添病院(長崎県)
長崎百合野病院(長崎県)
熊本大学(熊本県)
高野会 高野病院(熊本県)
済生会熊本病院(熊本県)
熊本赤十字病院(熊本県)
熊本中央病院(熊本県)
健康保険人吉総合病院(熊本県)
健康保険八代総合病院(熊本県)
荒尾市民病院(熊本県)
大分赤十字病院(大分県)
国立病院機構大分医療センター(大分県)
国立病院機構別府医療センター(大分県)
中津市立中津市民病院(大分県)
大分県立病院(大分県)
大分県済生会日田病院(大分県)
潤愛会 鮫島病院(鹿児島県)
鹿児島大学(鹿児島県)
鹿児島厚生連病院(鹿児島県)
県民健康プラザ鹿屋医療センター(鹿児島県)
鹿児島共済会南風病院(鹿児島県)
浦添総合病院(沖縄県)
中頭病院(沖縄県)
沖縄県立南部医療センター・こども医療センター(沖縄県)
琉球大学(沖縄県)
広島赤十字・原爆病院(広島県)
松山赤十字病院(愛媛県)
宮崎県立日南病院(宮崎県)
2010 | Year | 07 | Month | 14 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/26338269
Completed
2010 | Year | 03 | Month | 29 | Day |
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 07 | Month | 14 | Day |
2017 | Year | 01 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004706
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