UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005301 |
|---|---|
| Receipt number | R000006241 |
| Scientific Title | Phase II Study of Combination Epitope Peptides with gemcitabine for Advanced/metastatic Pancreatic Cancer |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2016/01/05 18:21:05 |
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Basic information
Public title
Phase II Study of Combination Epitope Peptides with gemcitabine
for Advanced/metastatic Pancreatic Cancer
Acronym
Phase II Study of Combination Epitope Peptides with gemcitabine
for Advanced/metastatic Pancreatic Cancer
Scientific Title
Phase II Study of Combination Epitope Peptides with gemcitabine
for Advanced/metastatic Pancreatic Cancer
Scientific Title:Acronym
Phase II Study of Combination Epitope Peptides with gemcitabine
for Advanced/metastatic Pancreatic Cancer
Region
| Japan |
Condition
Condition
Advanced/metastatic Pancreatic Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effectiveness 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
Progression free survival
Safety
Disease control rate
specific immune response
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
Combination Epitope Peptides with gemcitabine
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. Histological proven pancreatic cancer
2. age: over 20 years-old, under 80 years-old
3.PS:0 to 1(ECOG performance status score)
4. One or more RECIST lesions
5.chemo-naive
6. Good function of critical organs
7. Suspect for more than 3 months alive
8. Written informed consents
9.not to have rapid growth of liver metastasis and much ascites
Key exclusion criteria
1. Severe heart diseases
2. Wish for pregnancy
3. Active infection
4. Steroid or immunosuppressive therapy
5. Allergy for using epitope peptides
6. Mental and nervous disorder
7. Massive pleural or abdominal effusions
8. Rapid growth of liver metastasis
9. Doctors opinion
Target sample size
40
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
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
nobusuzu@yamaguchi-u.ac.jp
Sponsor or person
Institute
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Department of Digestive Surgery and Surgical Oncology
Institute
Department
Personal name
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
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
| 2011 | Year | 04 | Month | 01 | 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 | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
| 2011 | Year | 03 | Month | 24 | Day |
Last modified on
| 2016 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006241
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
