UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008668
Receipt No. R000010187
Scientific Title Phase II study of XELIRI and bevacizumab as second-line therapy in patients with metastatic colorectal cancer
Date of disclosure of the study information 2012/08/11
Last modified on 2015/02/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II study of XELIRI and bevacizumab as second-line therapy in patients with metastatic colorectal cancer
Acronym Phase II study of XELIRI and bevacizumab as second-line therapy
Scientific Title Phase II study of XELIRI and bevacizumab as second-line therapy in patients with metastatic colorectal cancer
Scientific Title:Acronym Phase II study of XELIRI and bevacizumab as second-line therapy
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness and safety of bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer previously treated with oxaliplatin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression Free Survival
Key secondary outcomes

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
Bevacizumab 7.5mg/kg day1
Irinotecan 160mg/m2 day1
Capecitabin 1,600mg/m2/day day1-15
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.Histological confirmation of colorectal cancer
2.Metastatic colorectal cancer which has prior therapy of Oxliplatin-based chemotherapy
3.Age over 20
4.Group(ECOG) Performance Status (PS) 0-1
5.Adequate organ function
6. Written consent is taken
Key exclusion criteria 1. Metastases to the CNS
2. Complication of cerebrovascular disease or symptoms within 1 years
3. 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
4. Patient with untreated traumatic bone fracture
5. History of gastrointestinal perforation within 1 year
6. uncontrolled peptic ulcer
7. Diathesis of bleeding (history of hemoptysis,including cavitation and/or necrosis in lung metastasis confirmed by imaging),coagulopathy.
8. Administering antithrombotic drug within 10 days before enrollment
9. anti-platelets therapy
10. History of thrombosis or cerebrovascular disorder 12. Serious heart disease
11. Uncontrolled high blood pressure
12. Massive pleural effusion or ascites that required drainage
13.Multiple primary cancer which heals within five years
14. Patient who have peripheral nerve disorder
15.Interstitial pneumonitis
16. Uncontrolled diarrhea
17.Severe infection disease
18. The patient who has the past of the organ transplantation to need an immunosuppressive drug
19.Pregnant or lactating women or women of childbearing potential
20.History of severe allergy with Bevacizumab or Capecitabine
21. History of adverse events related to DPD loss
22. Other conditions not suitable for this study
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Watanabe
Organization Kitasato University School of Medicine
Division name department of surgery
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa,Japan
TEL 042-778-8111
Email kcsgc@kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeo Sato
Organization Kitasato University School of Medicine
Division name department of surgery
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa,Japan
TEL 042-778-8111
Homepage URL
Email takeo@kitasato-u.ac.jp

Sponsor
Institute Kitasato university school of medicine
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 08 Month 11 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 Open public recruiting
Date of protocol fixation
2012 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 11 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 08 Month 10 Day
Last modified on
2015 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010187

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.