UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015707 |
|---|---|
| Receipt number | R000018214 |
| Scientific Title | Phase II study of modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer |
| Date of disclosure of the study information | 2014/11/17 |
| Last modified on | 2014/11/17 13:02:32 |
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Basic information
Public title
Phase II study of modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer
Acronym
Phase II study of modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer
Scientific Title
Phase II study of modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer
Scientific Title:Acronym
Phase II study of modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer
Region
| Japan |
Condition
Condition
borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of mFOLFIRINOX for patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
resection rate, response rate, histological effect, 2-year survival, relapse free survival, feasibility, dose intensity, relative dose intensity, postoperative complication, safety
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
To investigate the safety and efficacy of mFOLFIRINOX for patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer.
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
(1). Cytologically proved pancreatic adenocarcinoma or adenosquamous carcinoma; the case thought to be invasive pancreatic duct cancer.
(2). Borderline resectable pancreatic cancer or locally advanced unresectable pancreatic cancer.
(3). Metastatic pancreatic cancer with measurable lesion according to RECIST ver.1.1
(4). Age 20-75 years
(5). ECOG Performance Status (PS) 0-1
(6). Life expectancy of at least 12 weeks
(7). 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
(8). Written informed consent
Key exclusion criteria
(1). Prior radiotherapy or chemotherapy
(2). Grade 2 or greater peripheral neuropathy
(3). Blood transfusion, administration of blood products, or hematopoietic (e.g., G-CSF) support within 7 days before enrollment
(4). Having UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 gene
(5). Moderate ascites
(6). Intestinal pneumonitis or pulmonary fibrosis
(7). Watery stool within 3 days before enrollment
(8). Clinically significant heart disease
(9). Active infection (HBS,HCV)
(10). Uncontrolled diabetes mellitus
(11). Serious complications (organ failure, or uncontrolled diabetes mellitus)
(12). Serious complications (mental disorder, or central nervous system disorders)
(13). Serious drug allergy
(14). Active double cancer
(15). Pregnancy
(16). Treatment with atazanavir sulfate
(17). Inappropriate for this study judged by the attending physician
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiko Tsuchida |
Organization
Tokyo Medical University
Division name
Department of Gastrointestinal and Pediatric Surgery
Zip code
Address
6-7-1, Nishishinjuku, Shinjuku, Tokyo
TEL
03-3342-6111
akihikot@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Nagakawa |
Organization
Tokyo Medical University
Division name
Department of Gastrointestinal and Pediatric Surgery
Zip code
Address
6-7-1, Nishishinjuku, Shinjuku, Tokyo
TEL
03-3342-6111
Homepage URL
naga@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Department of Gastrointestinal and Pediatric Surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
東京医科大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 17 | 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 | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 17 | Day |
Last modified on
| 2014 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018214
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