UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028055 |
|---|---|
| Receipt number | R000032101 |
| Scientific Title | Phase II study of FOLFIRINOX for unresectable pancreatic cancer patients after discontinuation of Pegfilgrastim |
| Date of disclosure of the study information | 2017/07/04 |
| Last modified on | 2019/06/22 16:17:22 |
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Basic information
Public title
Phase II study of FOLFIRINOX for unresectable pancreatic cancer patients after discontinuation of Pegfilgrastim
Acronym
Discontinuation of PegG
Scientific Title
Phase II study of FOLFIRINOX for unresectable pancreatic cancer patients after discontinuation of Pegfilgrastim
Scientific Title:Acronym
Discontinuation of PegG
Region
| Japan |
Condition
Condition
Unresectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and effectiveness of discontinuation of pegfilgrastim for unresectable pancreatic cancer patients receiving FOLFIRINOX with pegfilgrastim
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of febrile neutropenia during the first 2 cycles of FOLFIRINOX
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Discontinuation of Pegfilgrastim
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)Histologically or cytologically proved pancreatic adenocarcinoma or adenosquamous carcinoma
2)Receiving >=2cycles of FOLFIRINOX with pegfilgrastim and no findings of FN
3)Age >=20, <75
4)ECOG Performance Status 0-1
5)Life expectancy >=12weeks
6)Meets the following criteria within 7days before enrollment
1. absolute neutrophil: >=2,000/mm3
2. platelet count: >=100,000/mm3
3. total bilirubin: =<2.0 mg/dL
7)No progressive radiological findings within 14days before enrollment.
8)Tumor is regarded as unresectable.
9)With appropriate drainage for obstructive jaundice
10)Written informed consent to participate in this study
Key exclusion criteria
1)Severe myelosuppression
2)Active infection (except viral hepatitis)
3)Serious complications (organ failure, or active peptic ulcer etc)
4)Severe diarrhea
5)Intestinal pneumonitis or pulmonary fibrosis
6)Treatment-resistant ascites or pleural effusion
7)Brain or meningeal metastasis
8)Pregnancy or breast-feeding
9)Any contraindication for FOLFIRINOX
10)Severe complication by administration of pegfilgrastim
11)Severe mental disorder, or central nervous system disorders
12)Contraindication for dynamic CT/MRI
13)Inappropriate for this study judged by the investigator
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yamashita |
Organization
Kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
920-8641
Address
13-1, Takaramachi, Kanazawa, Japan
TEL
076-265-2235
ytatsuya@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Terashima |
Organization
Kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
920-8641
Address
13-1, Takaramachi, Kanazawa, Japan
TEL
076-265-2235
Homepage URL
tera@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board, Kanazawa University
Address
13-1, Takaramachi, Kanazawa, Japan
Tel
076-265-2048
crc.irb-knz@esct.jp
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
| 2017 | Year | 07 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 03 | Day |
Last modified on
| 2019 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032101
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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