UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008668 |
|---|---|
| Receipt number | 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 | 2021/08/23 11:48:54 |
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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
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
takeo@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato university school of medicine
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 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2022 | 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 | 08 | Month | 10 | Day |
Last modified on
| 2021 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010187
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