UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013809 |
|---|---|
| Receipt number | R000016112 |
| Scientific Title | The pilot study of neoadjuvant chemotherapy of FIRINOX for patients with borderline resectable pancreatic cancer |
| Date of disclosure of the study information | 2014/04/25 |
| Last modified on | 2016/04/25 20:41:04 |
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Basic information
Public title
The pilot study of neoadjuvant chemotherapy of FIRINOX for patients with borderline resectable pancreatic cancer
Acronym
FIRINOX
Scientific Title
The pilot study of neoadjuvant chemotherapy of FIRINOX for patients with borderline resectable pancreatic cancer
Scientific Title:Acronym
FIRINOX
Region
| Japan |
Condition
Condition
Invasive ductal carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety, efficacy and optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy for Borderline resectable pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
(1)Adverse event
Key secondary outcomes
(1)R0 resection rate
(2)Resection rate
(3)Optimal number of courses administration of neoadjuvant chemotherapy
(4)Optimal duration of surgery to perform from neoadjuvant chemotherapy
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
neoadjuvant chemotherapy
4 courses of FIRINOX
L-OHP 85mg/m2 administration
CPT-11 150mg/m2
administration
5-FU 2,400mg/m2 46hours infusion
neoadjuvant chemotherapy
8 courses of FIRINOX
L-OHP 85mg/m2 administration
CPT-11 150mg/m2
administration
5-FU 2,400mg/m2 46hours infusion
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Pathologically proven invasive pancreatic ductal carcinoma
(2)Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)
1) Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma
2) Patients indicated distal pancreatectomy with en bloc celiac axis resection
(3)PS (ECOG) 0-1
(4)>=20 years old and < 75 years old
(5)First line treatment
(6)The following criteria must be satisfied in laboratory tests within 14 days of registration
White blood cell count <=12,000/mm3
Neutrophil count >=1,500/mm3
Platelet count >=100,000mm3
Total bilirubin <2.0mg/dL
Serum Creatinine <=upper limits of normal(ULN)
AST,ALT<= 2.5xULN
Albumin>=3.0g/dL
Hemoglobin>=9.0g/dL
(7)Written informed consent to participate in this study
(8)Pancreatic head carcinoma without biliary drainage
Key exclusion criteria
(1)Severe drug hypersensitivity
(2)Multiple primary cancers within 5 years
(3)Severe infection
(4)With grade 2 or more severe peripheral neuropathy
(5)With intestinal paralysys, ileus
(6)Interstitial pneumonia or pulmonary
(7)With uncontrollable pleural effusion or ascites
(8)Receiving atazanavir sulfate
(9)With uncontrollable diabetes
(10)With uncontrollable heart failure, angina, hypertension, arrhythmia
(11)With severe psychological symptoms
(12)With watery diarrhea
(13)Pregnant or lactating women, or
women with known or suspected pregnancy
(14)Inappropriate patients for entry on this study in the judgment of the investigator
(15)With UGT1A1*28 and/or
UGT1A1*6 polymorphisms
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Yamaue |
Organization
Wakayama Medical University
Division name
Second department of surgery
Zip code
Address
811-1 Kimiidera, Wakayama
TEL
073-447-2300
yamaue-h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Okada |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama
TEL
073-441-0613
Homepage URL
okada@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
神戸大学大学（兵庫県）、関西医科大学（大阪府）、奈良県立医科大学（奈良県）、大阪大学（大阪府）、広島大学（広島県）、名古屋大学（愛知県）、大阪府立成人病センター（大阪府）、大阪市立大学（大阪府）、和歌山県立医科大学（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 25 | 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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 28 | 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 | 04 | Month | 25 | Day |
Last modified on
| 2016 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016112
