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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004452
Receipt No. R000005329
Scientific Title Phase I clinical trial of peptide vaccine with UFT/LV for advanced or recurrent colorectal cancer
Date of disclosure of the study information 2010/10/27
Last modified on 2012/10/31

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Basic information
Public title Phase I clinical trial of peptide vaccine with UFT/LV for advanced or recurrent colorectal cancer
Acronym Phase I clinical trial of peptide vaccine with UFT/LV for colorectal cancer
Scientific Title Phase I clinical trial of peptide vaccine with UFT/LV for advanced or recurrent colorectal cancer
Scientific Title:Acronym Phase I clinical trial of peptide vaccine with UFT/LV for colorectal cancer
Region
Japan

Condition
Condition advanced or recurrent colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We performed phase I clinical trial of the peptide vaccine therapy together with anticancer drug for the advanced colorectal cancer to confirm the safety of the treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We confirm the safety of the peptide vaccine against colorectal cancer patient.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
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
80 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 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Yamamoto
Organization Tokyo Women's Medical University
Division name Department of gastroenterological surgery
Zip code
Address 8-1, Kawata-cho, Shinjuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Women's Medical University
Division name Department of gastroenterological surgery
Zip code
Address
TEL 03-3353-8111
Homepage URL
Email

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization human Genome Center, Institute of Medical Science, University of Tokyo
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

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 27 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2008 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2008 Year 07 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 26 Day
Last modified on
2012 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005329

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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