UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001437 |
|---|---|
| Receipt number | R000001745 |
| Scientific Title | Phase II study of FOLFIRI plus Bevacitumab in the treatment of Japanese patients with advanced colorectal cancer. |
| Date of disclosure of the study information | 2008/10/20 |
| Last modified on | 2013/08/23 09:11:14 |
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Basic information
Public title
Phase II study of FOLFIRI plus Bevacitumab in the treatment of Japanese patients with advanced colorectal cancer.
Acronym
JACCRO CC-03
Scientific Title
Phase II study of FOLFIRI plus Bevacitumab in the treatment of Japanese patients with advanced colorectal cancer.
Scientific Title:Acronym
JACCRO CC-03
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 the safety of FOLFIRI/Bevacitumab as a first line chemotherapy for the Japanese patients with advanced colorectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Time to tretment failure
Overall survival
Response rete
Safety
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
(1) Bevaciumab 5mg/Kg i.v. 90min.
(2) CPT-11 150mg/m2 i.v. 90min. and Isovorin 200mg/m2 i.v. 90min.
(3) 5-FU 400mg/m2 i.v. bolus and
5-FU 2400mg/m2 civ. 46 hours
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Histologically proven colorectal carcinoma.
(2)Writtened informed consent.
(3) Age 20-74.
(4) PS 0-1 (ECOG)
(5) Expected 3 months or over survival.
(6) Inoperable or reccurent colorectal cancer.
(7) No prior chemotherapy.
(8) Needs evaluable lesion.
(9) Needs adequate hematological function.
Key exclusion criteria
(1) Contraindications of using CPT-11, Bevacitumab, 5-FU and Leucovorin
(2) Having double or more cancers within 5 yeras.
(3).Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant.
(4) Any subject judged by the investigator to be unfit for any reason to participate in the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsugu Kochi |
Organization
Nihon Universuty School of Medicine
Division name
Department of Digestive Surgery
Zip code
Address
30-1, Oyaguchi-kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
kochi.mitsugu@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshifusa Nakajima |
Organization
Japan Clinical Cancer Research Organization
Division name
Chief Director
Zip code
Address
3-10-6, Ariake, Kotoku, Tokyo
TEL
03-3570-0437
Homepage URL
jaccro@jaccro.or.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization
Institute
Department
Personal name
Funding Source
Organization
Japan Clinical Cancer Research Organization
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
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
| 2008 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2008 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 10 | Month | 18 | Day |
Last modified on
| 2013 | 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=R000001745
