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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007547
Receipt No. 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

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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
Email 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/
Email norifumi@med.nagoya-u.ac.jp

Sponsor
Institute Chubu Clinical Oncology Group (CCOG)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008900

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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