UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007547 |
|---|---|
| Receipt number | R000008900 |
| Scientific Title | Multicenter randomized phase ll study of XELOX plus bevacizumab or XELIRI plusbevacizumab as first-line chemotherapy for metastatic or recurrent colorectal cancer |
| Date of disclosure of the study information | 2012/03/22 |
| Last modified on | 2016/11/16 09:01:49 |
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Basic information
Public title
Multicenter randomized phase ll study of XELOX plus bevacizumab or XELIRI plusbevacizumab as first-line chemotherapy for metastatic or recurrent colorectal cancer
Acronym
Multicenter randomized phase ll study of XELOX plus bevacizumab or XELIRI plusbevacizumab as first-line chemotherapy for metastatic or recurrent colorectal cancer(CCOG1201)
Scientific Title
Multicenter randomized phase ll study of XELOX plus bevacizumab or XELIRI plusbevacizumab as first-line chemotherapy for metastatic or recurrent colorectal cancer
Scientific Title:Acronym
Multicenter randomized phase ll study of XELOX plus bevacizumab or XELIRI plusbevacizumab as first-line chemotherapy for metastatic or recurrent colorectal cancer(CCOG1201)
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of XELOX plus bevacizumab and XELIRI plus bevacizumab in advanced colorectal cancer as 1st line chemotherapies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
ORR; Overall response rate
Key secondary outcomes
PFS; Progression free survival DDC;Duration of disease control
TTF; Time to treatment failure
OS; Overall survival
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
XELOX plus bevacizumab therapy
Bevacizumab 7.5mg/kg day1
Oxaliplatin 130mg/m2 day1
Capecitabin 2,000mg/m2/day day1-15
Interventions/Control_2
XELIRI plus bevacizumab therapy
Bevacizumab 7.5mg/kg day1
Irinotecan 200mg/m2 day1
Capecitabin 1,600mg/m2/day day1-15
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Histopathologically confirmed colorectal cancer
(2)Unresectable and Untreated advanced colorectal cancer patients
(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
Key exclusion criteria
(1)Uncontrolled infection.
(2)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated
(3)Previous history of thoromboembolitic disease,or necessity for antithrombotic drug.
(4)Severe lung disease.(Interstitial lung disease or pulmonary fibrosis.)
(5)Severe liver disease.
(6)Severe renal failure.
(7)Previous history of severe drug-induced allergy
(8)Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer.
(9)History of gastrointestinal perforation within 1 year.
(10)Uncontrolled severe complications(DM, hypertension, diarrhea, et al.)
(11)History of active double cancer.
(12)Massive pleural effusion or ascites that required drainage.
(13)Brain metastasis
(14)Patients with psycho-neurological disease,central nervous system damage,cerebrovascular disorder
(15)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.
(16)Patient with untreated traumatic bone fracture.
(17)Diathesis of bleeding (history of hemoptysis,including cavitation and/or necrosis in lung metastasis confirmed by imaging),coagulopathy.
(18) Systemic administration of antiplatelet drug
(19)Patient who have peripheral nerve disorder
(20)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
(21)Not appropriate for the study at the physician's assessment.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goro Nakayama |
Organization
Nagoya University Gradeate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan
TEL
(81)52-744-2250
goro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyuki Aoki |
Organization
Chubu Clinical Oncology Group (CCOG)
Division name
Data Center
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan
TEL
(81)52-744-2253
Homepage URL
http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/
norifumi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Chubu Clinical Oncology Group (CCOG)
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 21 | Day |
Last modified on
| 2016 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008900
