UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004389 |
|---|---|
| Receipt number | R000005245 |
| Scientific Title | PhaseI/II clinical study of peptide vaccine against advanced or recurrent gastric cancer |
| Date of disclosure of the study information | 2010/10/18 |
| Last modified on | 2012/04/16 15:05:37 |
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Basic information
Public title
PhaseI/II clinical study of peptide vaccine against advanced or recurrent gastric cancer
Acronym
PhaseI/II clinical study of peptide vaccine against advanced or recurrent gastric cancer
Scientific Title
PhaseI/II clinical study of peptide vaccine against advanced or recurrent gastric cancer
Scientific Title:Acronym
PhaseI/II clinical study of peptide vaccine against advanced or recurrent gastric cancer
Region
| Japan |
Condition
Condition
Advanced or recurrent gastric cancer refractory to standard therapeutic modality
Classification by specialty
| Medicine in general | Gastroenterology | Surgery in general |
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety
Overall survival
Key secondary outcomes
Time to treatment failure
Progression free survival
Antitumor immune responses
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 | Vaccine |
Interventions/Control_1
Peptide vaccine therapy
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Performance Status 0-1
Refractory to standard therapy
Key exclusion criteria
Pregnancy
Uncontrolled infection
Patients with serious concomitant disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujiwara Yoshiyuki |
Organization
Graduate School of Medicine,Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2,Yamadaoka,Suita,Osaka,Japan
TEL
06-6879-3251
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujiwara Yoshiyuki |
Organization
Graduate School of Medicine,Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2,Yamadaoka,Suita,Osaka,Japan
TEL
06-6879-3251
Homepage URL
yfujiwara@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery,Graduate School of Medicine,Osaka University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institute of Medical Science , University of Tokyo
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
大阪大学病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
| 2010 | Year | 10 | Month | 14 | Day |
Last modified on
| 2012 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005245
