UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014658 |
|---|---|
| Receipt number | R000017052 |
| Scientific Title | Observational study of FOLFIRINOX therapy for unresectable and recurrence pancreatic cancer |
| Date of disclosure of the study information | 2014/07/26 |
| Last modified on | 2018/05/17 08:25:14 |
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Basic information
Public title
Observational study of FOLFIRINOX therapy for unresectable and recurrence pancreatic cancer
Acronym
JASPAC 06
Scientific Title
Observational study of FOLFIRINOX therapy for unresectable and recurrence pancreatic cancer
Scientific Title:Acronym
JASPAC 06
Region
| Japan |
Condition
Condition
unresectable and recurrence pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of FOLFIRINOX therapy for patients with unresectable and recurrence pancreatic cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adverse events
severe adverse events
Key secondary outcomes
dose intensity, the reasons for dose reduction and delay, progression free survival, overall survival
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed as unresectable and recurrence pancreatic cancer, and received or will be received FOLFIRINOX therapy (oxaliplatin, irinotecan, levofolinate calcium and fluorouracil) between 20th Dec. 2013 and 19th Dec. 2014.
2) Written informed consent, but it is not necessary for the patients who discontinued protocol therapy.
Key exclusion criteria
1) Histologically proven not to be a malignant pancreatic exocrine tumor
2) Not administered all of oxaliplatin, irinotecan, levofolinate calcium and fluorouracil
Target sample size
329
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Fukutomi |
Organization
Shizuoka Cancer Center
Division name
Division of GI Oncology and Endoscopy
Zip code
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, JAPAN
TEL
055-989-5222
a.fukutomi@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Todaka |
Organization
Shizuoka Cancer Center
Division name
Division of GI Oncology and Endoscopy
Zip code
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, JAPAN
TEL
055-989-5222
Homepage URL
a.todaka@scchr.jp
Sponsor or person
Institute
Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
Institute
Department
Personal name
Funding Source
Organization
Public Interest Incorporated Foundation
Shizuoka Industrial Foundation
Pharma Valley Center
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
| 2014 | Year | 07 | Month | 26 | 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
| 2014 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients received FOLFIRINOX therapy between 20th Dec. 2013 and 19th Dec. 2014 will be enrolled. Regardless of retorospective or prospective, all cases will be collectively analyzed.
Management information
Registered date
| 2014 | Year | 07 | Month | 26 | Day |
Last modified on
| 2018 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017052
