UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004630 |
|---|---|
| Receipt number | R000005527 |
| Scientific Title | Study of Bevacizumab + Irinotecan + S-1 therapy in metastatic colorectal cancer with KRAS mutant type |
| Date of disclosure of the study information | 2010/11/30 |
| Last modified on | 2012/12/10 03:09:24 |
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Basic information
Public title
Study of Bevacizumab + Irinotecan + S-1 therapy in metastatic colorectal cancer with KRAS mutant type
Acronym
Study of Bevacizumab + Irinotecan + S-1 therapy in metastatic colorectal cancer with KRAS mutant type
Scientific Title
Study of Bevacizumab + Irinotecan + S-1 therapy in metastatic colorectal cancer with KRAS mutant type
Scientific Title:Acronym
Study of Bevacizumab + Irinotecan + S-1 therapy in metastatic colorectal cancer with KRAS mutant type
Region
| Japan |
Condition
Condition
Metastatic 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 Irinotecan + S-1 + Bevacizumab as first line in metastatic colorectal cancer with KRAS mutant type
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Progression Free Survival(PFS)
Overall Survival(OS)
Safety
Best response: % change at baseline
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
IRIS + Bevacizumab
Bevacizumab 5mg/kg/biweekly
Irinotecan 100 mg/m2/biweekly
S-1 80,100,120 mg/twice/day 1-14, following two weeks off
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) Patients with histologically proven colorectal cancer
(2) Metastatic colorectal cancer
(3) KRAS mutant type
(4) Patients with comfirmed target lesion
(5) No prior chemotherapy for metastatic colorectal cancer
(6) Life expectancy of more than 3 months
(7) Age over 20
(8) ECOG Performance Status 0-1
(9) Patients have enough organ function for study treatment.
(10) Enable to internal use
(11) Written informed consent
Key exclusion criteria
(1) History of severe allergy
(2) Active double cancer
(3) Severe infectious disease
(4) Intestinal tract paralysis or intestinal obstruction
(5) Uncontrolled hypertention
(6) Sever comorbidity(interstitial lung disease or pulmonary fibrosis, heart failure, renal failure, liver failure, etc)
(7) Massive pleural or abdominal effusion
(8) Patient with the diarrhea
(9) Symptomatic brain metastases
(10) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
(11) Severe mental disorder
(12) Systemic administration of corticosteroids
(13) Uric protein 2+
(14) Prior radiotherapy for primary and metastases tumors
(15) Thrombosis, cerebral infraction, cardiac infraction or pulmonary infraction within 6 months
(16) Patients who underwent surgery within 4 weeks
(17) Systemic administration of antiplatelet drug
(18) Patients with known bleeding disorders or clotting disorder
(19) Any other cases who are regarded as inadequate for study enrollmet by investigators
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Sakai |
Organization
Tsuchiura kyodo general hospital
Division name
Department of Gastroenterology
Zip code
Address
11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiki Masuishi |
Organization
Tsuchiura kyodo general hospital
Division name
Department of Gastroenterology
Zip code
Address
11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
TEL
Homepage URL
Sponsor or person
Institute
Tsuchiura kyodo general hospital
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
| 2010 | Year | 11 | Month | 30 | 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
| 2010 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | 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
| 2010 | Year | 11 | Month | 30 | Day |
Last modified on
| 2012 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005527
