Unique ID issued by UMIN | UMIN000011679 |
---|---|
Receipt number | R000013645 |
Scientific Title | Phase II study of XELOX plus bevacizumab as second-line chemotherapy prior oral fluoropyrimidine,oxaliplatin plus bevacizumab for metastatic colorectal cancer |
Date of disclosure of the study information | 2013/09/08 |
Last modified on | 2016/11/16 09:09:27 |
Phase II study of XELOX plus bevacizumab as second-line chemotherapy prior oral fluoropyrimidine,oxaliplatin plus bevacizumab for metastatic colorectal cancer
CCOG1202
Phase II study of XELOX plus bevacizumab as second-line chemotherapy prior oral fluoropyrimidine,oxaliplatin plus bevacizumab for metastatic colorectal cancer
CCOG1202
Japan |
Unresectable metastatic or recurrent colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and safety of XELOX plus bevacizumab as second-line chemotherapy for unresectable metastatic or recurrent colorectal cancer patients who have failed prior oral fluoropyrimidine, oxaliplatin plus bevacizumab
Safety,Efficacy
Exploratory
Pragmatic
Phase II
ORR;Overall response rate
PFS;Progression free-survival
TTF;Time to treatment-failure
OS;Overall survival
safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
XELOX plus bevacizumab therapy
Bevacizumab 7.5mg/kg day1
irinotecan 130mg/m2 day1
Capecitabin 1600mg/m2/day day1-15
20 | years-old | <= |
Not applicable |
Male and Female
(1)Histopathologically confirmed colorectal cancer
(2)Unresectable advanced colorectal cancer patient who have failed prior oral fluoropyrimidine , irinotecan plus bevacizumab
(3)Age of 20 years or older
(4)ECOG performance status 0-1
(5)Measurable or evaluable disease (RECIST ver.1.1.)
(6)Alife expectancy greater than 3 months
(7)satisfactory oral feeding
(8)Adequate organ function
(9)Written informed concent
1)Treatment of TS-1 within a week.
2)Patient who had treatment including irinotecan.
3)Uncontrolled infection.
4)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated
5)Previous history of thoromboembolitic disease,or necessity for antithrombotic drug.
6)Severe lung disease.(Interstitial lung disease or pulmonary fibrosis.)
7)Severe liver disease.
8)Severe renal failure.
9)Previous history of severe drug-induced allergy
10)Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer.
11)History of gastrointestinal perforation within 1 year.
12)Uncontrolled severe complications(DM, hypertension, diarrhea, et al.)
13)History of active double cancer.
14)Massive pleural effusion or ascites that required drainage.
15)Brain metastasis
16)Patients with psycho-neurological disease,central nervous system damage,cerebrovascular disorder
17)Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week.
18)Patient with untreated traumatic bone fracture.
19)Diathesis of bleeding (history of hemoptysis,including cavitation and/or necrosis in lung metastasis confirmed by imaging),coagulopathy.
20) Systemic administration of antiplatelet drug
21)Administration of immunosuppressants associated with organ transplantation
22)Patient who have peripheral nerve disorder
23)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
24)Not appropriate for the study at the physician's assessment
25
1st name | |
Middle name | |
Last name | Goro Nakayama |
Nagoya University Graduate School of Medicine
Department of Gastroenterology
65 Tsurumai-cho Showa-ku Nagoya-city Aichi Japan
(81)52-744-2253
goro@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Miyuki Aoki |
Clinical Oncology Group(CCOG)
Data Center
65 Tsurumai-cho Showa-ku Nagoya-city Aichi Japan
(81)52-744-2253
http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/
norifumi@med.nagoya-u.ac.jp
Chubu Clinical Oncology Group
None
Self funding
NO
2013 | Year | 09 | Month | 08 | Day |
Unpublished
Enrolling by invitation
2012 | Year | 04 | Month | 01 | Day |
2012 | Year | 04 | Month | 04 | Day |
2013 | Year | 09 | Month | 08 | Day |
2016 | Year | 11 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013645
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |