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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007505
Receipt No. R000007714
Scientific Title Phase II Study of Combination Epitope Peptides for Advanced/metastatic Pancreatic Cancer
Date of disclosure of the study information 2012/03/14
Last modified on 2016/01/05

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Basic information
Public title Phase II Study of Combination Epitope Peptides
for Advanced/metastatic Pancreatic Cancer
Acronym Phase II Study of Combination Epitope Peptides
for Advanced/metastatic Pancreatic Cancer
Scientific Title Phase II Study of Combination Epitope Peptides
for Advanced/metastatic Pancreatic Cancer
Scientific Title:Acronym Phase II Study of Combination Epitope Peptides
for Advanced/metastatic Pancreatic Cancer
Region
Japan

Condition
Condition Advanced/metastatic Pancreatic Cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigation of the effectiveness and Safety of Combination Epitope Peptides with gemcitabine for Advanced/metastatic Pancreatic Cancer as first line therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall survival
Key secondary outcomes Response rate
Safety
immune response
Progression free survivial
QOL

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 Epitope Peptides
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Histological proven pancreatic cancer
2.age: over 20 years-old
3.PS:0 to 2(ECOG performance status score)
4.One or more RECIST lesions
5.
6.
7.Suspect for more than 3 months alive
8.Written informed consents
9.not to have rapid growth of liver metastasis and much ascites
10.
11.
Key exclusion criteria 1.Severe heart diseases
2.
3.Wish for pregnancy
4.Active infection
5.Steroid or immunosuppressive therapy
6.Allergy for using epitope peptides
7.Mental and nervous disorder
8.Massive pleural or abdominal effusions
9.Rapid growth of liver metastasis
10.Doctors opinion
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Oka
Organization YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name Department of Digestive Surgery and Surgical Oncology
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2264
Email geka2dm@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuaki Suzuki
Organization YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name Department of Digestive Surgery and Surgical Oncology
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2264
Homepage URL
Email geka2dm@yamaguchi-u.ac.jp

Sponsor
Institute YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Department of Digestive Surgery and Surgical Oncology
Institute
Department

Funding Source
Organization YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Department of Digestive Surgery and Surgical Oncology
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
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 山口大学大学院 消化器・腫瘍外科学(YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE Department of Digestive Surgery and Surgical Oncology)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 14 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
2010 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2010 Year 09 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
2012 Year 03 Month 14 Day
Last modified on
2016 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007714

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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