UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014259 |
|---|---|
| Receipt number | R000016610 |
| Scientific Title | Cohort study of FOLFIRINOX as third-line chemotherapy for metastatic pancreatic cancer. |
| Date of disclosure of the study information | 2014/06/16 |
| Last modified on | 2014/06/13 19:00:43 |
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Basic information
Public title
Cohort study of FOLFIRINOX as third-line chemotherapy for metastatic pancreatic cancer.
Acronym
Cohort study of FOLFIRINOX as third-line chemotherapy for metastatic pancreatic cancer.
Scientific Title
Cohort study of FOLFIRINOX as third-line chemotherapy for metastatic pancreatic cancer.
Scientific Title:Acronym
Cohort study of FOLFIRINOX as third-line chemotherapy for metastatic pancreatic cancer.
Region
| Japan |
Condition
Condition
Unresectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of FOLFIRINOX as third-line chemotherapy for unresectable pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Unresectable metastatic or recurrence pancreatic cancer
2) Refractory and intolerable to gemcitabine and S-1
3) Histlogically proven adenocarcinoma
4) Age >= 18 years
5) ECOG performance status of 0, 1
6) Adequate bone marrow, hepatic, renal, cardiac and respiratory functions
7) 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) serious coexisting illness
5) other medical condition unacceptable for entry
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Tsuji |
Organization
Kobe City Medical Center General Hospital
Division name
medical oncology
Zip code
Address
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL
0783024321
t-kotake@kcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Okita |
Organization
Kobe City Medical Center General Hospital
Division name
medical oncology
Zip code
Address
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL
0783024321
Homepage URL
yokita@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
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
| 2014 | Year | 06 | Month | 16 | 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
| 2014 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate efficacy and safety of FOLFIRINOX as third-line chemotherapy for Japanese patiants
Management information
Registered date
| 2014 | Year | 06 | Month | 13 | Day |
Last modified on
| 2014 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016610
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
