UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013301 |
|---|---|
| Receipt number | R000015456 |
| Scientific Title | Phase II trial of modified FOLFIRINOX (irinotecan plus oxaliplatin and 5-fluorouracil/leucovorin) in patients with untreated metastatic pancreatic cancer |
| Date of disclosure of the study information | 2014/02/28 |
| Last modified on | 2015/01/26 11:55:56 |
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Basic information
Public title
Phase II trial of modified FOLFIRINOX (irinotecan plus oxaliplatin and 5-fluorouracil/leucovorin) in patients with untreated metastatic pancreatic cancer
Acronym
modified FOLFIRINOX
Scientific Title
Phase II trial of modified FOLFIRINOX (irinotecan plus oxaliplatin and 5-fluorouracil/leucovorin) in patients with untreated metastatic pancreatic cancer
Scientific Title:Acronym
modified FOLFIRINOX
Region
| Japan |
Condition
Condition
untreated metastatic 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 efficacy and safety of modified FOLFIRINOX in metastatic pancreatic cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall survival
Key secondary outcomes
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
modified FOLFIRINOX
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Histologically or cytologically proved pancreatic adenocarcinoma or adenosquamous carcinoma
Age 20-75 years
ECOG Performance Status (PS) 0-1
Metastatic pancreatic cancer with measurable lesion according to RECIST ver.1.1
Meets the following criteria within 7days before enrollment
absolute neutrophil count<2,000/uL, platelet count<100,000/uL, hemoglobin<9 g,/dL, white blood cell count<10,000/uL, bilirubin < ULN, AST and ALT < 2.5 X ULN, CRP<2.0mg/dl
Written informed consent
Key exclusion criteria
Prior radiotherapy or chemotherapy
Homotype of UGT1A1 genotype including *28/*28, *6/*6 and*6/*28
Evident pleural effusion, ascites, pericardial effusion or peritoneal metastasis on CT before enrollment
Pulmonary fibrosis or interstitial pneumonia
Watery stool within 3 days before enrollment
Uncontrolled diabetes mellitus
Any serious complication
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ishii |
Organization
Cancer Institute Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-8-31 Ariake, Koto-ward, Tokyo
TEL
03-3520-0111
hiroshi.ishii@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Ozaka |
Organization
Cancer Institute Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-8-31 Ariake, Koto-ward, Tokyo
TEL
03-3520-0111
Homepage URL
masato.ozaka@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
Organization
Division
Category of Funding Organization
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 | 02 | 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
| 2013 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 20 | 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
| 2014 | Year | 02 | Month | 28 | Day |
Last modified on
| 2015 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015456
