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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009280
Receipt No. R000010902
Scientific Title A Phase II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
Date of disclosure of the study information 2012/11/07
Last modified on 2019/11/11

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Basic information
Public title A Phase II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
Acronym JSWOG C3
Scientific Title A Phase II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
Scientific Title:Acronym JSWOG C3
Region
Japan

Condition
Condition advanced and/or recurrent colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of XELIRI plus bevacizumab in advanced colorectal cancer as second-line chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes progression free survival and safety
Key secondary outcomes overall survival,time to progression, and safety,Response rate,Dose Intensity,and Analysis of the safety and efficacy of CPT-11-containing regimens based on genetic polymorphisms UGT1As

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 XELIRI plus bevacizumab therapy
Capecitabine: 2000 mg/m2 day1 to 8
CPT11 150mg/m2 day1
Bevacizumab: 10mg/kg day 1
The treatment is repeated every two weeks until disease progression or severe toxicity.
Interventions/Control_2
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) Written informed consent after the explanation of the content of the examination
(2) Age of 20 years or elder
(3) ECOG performance status of 0 and 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 prior therapy of Oxalipalatin based chemotherapy
(8) Adequate organ functions
Key exclusion criteria (1) Massive pleural effusion or ascites that required drainage
(2) Severe liver disease
(3) Severe renal function disorder, 2+ or higher proteinuria within 2 weeks prior to enrollment
(4) Severe renal failure
(5) Metastases to the CNS
(6) History of active double cancer within 5 years
(7) Complication of cerebrovascular disease or symptoms within 1 year
(8) 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
(9) Radiation therapy within 4 weeks before enrollment
(10) Administering antithrombotic drug within 10 days before enrollment
(11) bleeding diathesis or receiving anticoagulant drug(except Aspirin under 325mg/day)
(12) A bleeding tendency, coagulation disorder or abnormal coagulation factor
(13) Uncontrollable peptic ulcer
(14) History of gastrointestinal perforation within 1 year.
(15) Patient with untreated traumatic bone fracture
(16) Uncontrollable hypertension
(17) Serious heart disease
(18) History of severe allergy with 5-FU
(19) Uncontrollable diarrhea
(20) Interstitial pneumonitis
(21) Inability of oral Agent intake
(22) Requiring novel immunosuppressant and steroid
(23) Receiving atazanavir sulfate
(24) Severe infection disease
(25) Treatment history of CPT-11
(26) Other conditions not suitable for this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Shoichi
Middle name
Last name Hazama
Organization Yamaguchi University
Division name Digestive surgery and surgical oncology
Zip code 755-8505
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL +81-836-22-2264
Email hazama@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Shoichi
Middle name
Last name Hazama
Organization YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name Digestive surgery and surgical oncology
Zip code 755-8505
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL +81-836-22-2264
Homepage URL
Email hazama@yamaguchi-u.ac.jp

Sponsor
Institute NPO Japan Southwest Oncology Research Support Organization(JSWOG)
Institute
Department

Funding Source
Organization NPO Japan Southwest Oncology Research Support Organization(JSWOG)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yamaguchi University
Address 1-1-1 Minamikogushi , Ube, 755-8505, Japan
Tel 0836-22-2428
Email clin_res@yamaguchi-u.ac.jp

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 11 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 51
Results
51 patients were enrolled in this study. Median PFS was 5.5 months, and median OS was 13.5 months. The RR was 14.6%, and the DCR was 66.7%. Hypertension was the most common Grade 3 adverse event (27.5%), followed by neutropenia (17.6%). Only two patients suffered from grade 3 hand-foot syndrome. In mCRC patients, biweekly CAPIRI + bevacizumab appears effective and feasible as a second-line chemotherapy with relatively low toxicities, and has potential as a useful substitute for FOLFIRI + bevacizumab.
Results date posted
2019 Year 11 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 05 Month 29 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 10 Month 19 Day
Date of IRB
2012 Year 10 Month 31 Day
Anticipated trial start date
2012 Year 11 Month 07 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 07 Day
Last modified on
2019 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010902

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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