UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017538
Receipt No. R000020312
Scientific Title Phase II study of pegfilgrastim as support to metastatic pancreatic cancer patients receiving FOLFIRINOX
Date of disclosure of the study information 2015/05/15
Last modified on 2015/05/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II study of pegfilgrastim as support to metastatic pancreatic cancer patients receiving FOLFIRINOX
Acronym Phase II study of pegfilgrastim as support to metastatic pancreatic cancer patients receiving FOLFIRINOX
Scientific Title Phase II study of pegfilgrastim as support to metastatic pancreatic cancer patients receiving FOLFIRINOX
Scientific Title:Acronym Phase II study of pegfilgrastim as support to metastatic pancreatic cancer patients receiving FOLFIRINOX
Region
Japan

Condition
Condition Metastatic pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and effectiveness of pegfilgrastim as primary prophyraxis in patients with metastatic pancreatic cancer receiving FOLFIRINOX
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes incidence of febrile neutropenia during the first 3 cycles of treatment
Key secondary outcomes Overall Survival, Progression Free Survival, Response Rate, Relative Dose Intensity, Adverse events, Severe adverse events

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 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)ECOG Performance Status 0-1
3)Metastatic pancreatic cancer with measurable lesion according to RECIST ver.1.1
4)Meets the following criteria within 7days before enrollment
hemoglobin: >9 g/dL
absolute neutrophil: >2000/mm3
platelet count: >100,000/mm3
AST and ALT: <2.5 X ULN
total bilirubin: <ULN
serum creatinine: <1.2mg/dL
5)written informed consent to participate in this study
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)UGT genetic polymorphisms of homozygous UGT1A1*6 or UGT1A1*28 or heterozygous UGT1A1*6 and *28
5)confirm the presence of ascites or peritoneal metastasis by imaging
6)Intestinal pneumonitis or pulmonary fibrosis
7)severe diarrhea within 3 days before enrollment
8)Clinically significant heart disease
9)Active infection (except HBV+,HCV+)
10)Poor glycemic control diabetes mellitus
11)Serious complications (organ failure, or active peptic ulcer etc)
12)Severe mental disorder, or central nervous system disorders
13)Serious drug allergy
14)Active double cancer
15)Brain or meningeal metastasis
16)Pregnancy
17)Treatment with atazanavir sulfate
18)Inappropriate for this study judged by the investigator
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Ueno
Organization National Cancer Center Hospital
Division name Department of Hepatobiliary Pancreatic Oncology
Zip code
Address 5-1-1 Tsukiji Chuo-ku Tokyo
TEL 03-3542-2511
Email hiueno@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhito Sasaki
Organization National Cancer Center Hospital
Division name Department of Hepatobiliary Pancreatic Oncology
Zip code
Address 5-1-1 Tsukiji Chuo-ku Tokyo
TEL 03-3542-2511
Homepage URL
Email mitsasak@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
Email

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
2015 Year 05 Month 15 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
2015 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 01 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
2015 Year 05 Month 13 Day
Last modified on
2015 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020312

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.