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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004332
Receipt No. R000005189
Scientific Title Phase I/II study of postoperative adjuvant therapy with Gemcitabine plus peptide vaccine for pancreatic cancer.
Date of disclosure of the study information 2010/10/06
Last modified on 2012/10/31

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Basic information
Public title Phase I/II study of postoperative adjuvant therapy with Gemcitabine plus peptide vaccine for pancreatic cancer.
Acronym Phase I/II study of postoperative adjuvant therapy with Gemcitabine plus peptide vaccine for pancreatic cancer.
Scientific Title Phase I/II study of postoperative adjuvant therapy with Gemcitabine plus peptide vaccine for pancreatic cancer.
Scientific Title:Acronym Phase I/II study of postoperative adjuvant therapy with Gemcitabine plus peptide vaccine for pancreatic cancer.
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the safety and clinical efficacy of Gemicitabine plus peptide vaccine for pancreatic cancer in an adjuvant setting.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Assessment of safety
Postoperative progression free survival
Postoperative overall survival
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 Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine Vaccine
Interventions/Control_1 Patients will be treated with Gemcitabine within 10 weeks after curative operation and vaccinated biweekly for 12 times. On each vaccination day, VEGFR1 and VEGFR2 peptide (1mg) are mixed with Montanide ISA-51 will be administered by subcutaneous injection.
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.HLA-A2402 positive pancreatic cancer patients who received the curative operation
2.Age between 20 to 80
3.No severe organ function impairment
4.Written informed consent of the patient
5.Performance Status 0-2
Key exclusion criteria 1.Pregnancy or lactation
2.Decision of unsuitableness by principal investigatior
3.Patient with severe underlying disease
4.Patient with severe allergy disease
Target sample size 20

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 Kawada-cho, Shinjyuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Hatori
Organization Tokyo Women's Medical University
Division name Department of Gastroenterological Surgery
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku. Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Department of Gastroenterological Surgery, Tokyo Women's Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Human Genome Center, Institute of Medical Science, The University of Tokyo
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 東京女子医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 06 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
2008 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2008 Year 01 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 06 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=R000005189

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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