UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013711 |
|---|---|
| Receipt number | R000016009 |
| Scientific Title | Phase I study of FOLFOXIRI+Cmab in patients with KRAS wild-type unresectable colorectal cancer |
| Date of disclosure of the study information | 2014/04/28 |
| Last modified on | 2022/05/18 15:55:07 |
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Basic information
Public title
Phase I study of FOLFOXIRI+Cmab in patients with KRAS wild-type unresectable colorectal cancer
Acronym
TRICETU study
Scientific Title
Phase I study of FOLFOXIRI+Cmab in patients with KRAS wild-type unresectable colorectal cancer
Scientific Title:Acronym
TRICETU study
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Determining the maximum tolerable dose(MTD) and recommended dose(RD)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Proportion of dose limiting toxicity
Key secondary outcomes
safety (adverse event, completion rate), efficacy (overall survival, progression free survival, response rate)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
5FU
Leucovorin
Irinotecan
Oxaliplatin
Cetuximab
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) Unresectable metastatic or recurrence colorectal cancer
2) Histlogically proven colorectal carcinoma
3) KRAS wild-type
4) Age >= 18 years
5) ECOG performance status of 0, 1
6) Previous L-OHP based adjuvant chemotherapy was allowed if relapsed more than 6 months after last administration
7) UGT1A1*6*28 wild type or single hetero
8) No prior chemotherapy and radiotherapy for other malignancies
9) Adequate bone marrow, hepatic, renal, cardiac and respiratory functions
10) Written informed consent
Key exclusion criteria
1) active synchronous or metachronous malignancy other than carcinoma in situ
2) pregnant or nursing
3) severe mental disorders
4) systemic steroid user
5) diabetes mellitus, uncontrolled
6) history of myocardial infarction, unstable angina within 3 months prior to the registration
7) serious coexisting illness
8) active infection
9) peripheral neuropathy greater than Grade 2
10) ileus
11) massive pleural effusion,ascites
12) history for allergy of L-OHP,CPT-11,5-FU,L-LV,bevacizumab
13) Receiving Atazanavir
14) KRAS mutant-type
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hisateru |
| Middle name | |
| Last name | Yasui |
Organization
Kobe City Medical Center General Hospital
Division name
medical oncology
Zip code
650-0047
Address
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL
078-302-4321
hyasui@kcho.jp
Public contact
Name of contact person
| 1st name | Hisateru |
| Middle name | |
| Last name | Yasui |
Organization
Kobe City Medical Center General Hospital
Division name
medical oncology
Zip code
650-0047
Address
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL
078-302-4321
Homepage URL
hsatake@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe City Medical Center General Hospital
Address
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
Tel
078-302-4321
ctc-crc@kcho.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
神戸市立医療センター中央市民病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 28 | 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
| 2014 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 14 | Day |
Last modified on
| 2022 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016009
