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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009167
Receipt No. R000010756
Scientific Title Clinical efficacy of novel cancer vaccines
Date of disclosure of the study information 2012/11/01
Last modified on 2017/03/16

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Basic information
Public title Clinical efficacy of novel cancer vaccines
Acronym Cancer vaccine
Scientific Title Clinical efficacy of novel cancer vaccines
Scientific Title:Acronym Cancer vaccine
Region
Japan

Condition
Condition Incurable lung, esophageal, colorectal, gastric, gallbladder, or breast cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Primary: progression-free survival
Secondary: OS, RR, safety, immune responses
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes OS, RR, safety, immune responses

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 cancer peptide vaccine
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) histologically proven advanced or metastatic lung (NSCLC), esophageal, colorectal, gastric, gallbladder, or breast cancer
2) measurable lesions
3) HLA-A2402
4) withdrawn from previous treatments
5) Performance Status (P.S.) of 0-1
6) life expectancy of 3 months
7) preserved organ functions
8) written informed concent
9) no desire of pregnancy in female patients
Key exclusion criteria 1) autoimmune disease
2) uncontrolled complications
3) pregnant
4) allergy of contrast enhancements
5) systemic symptom(s) of dyspnea, jaundice, edema, effusions, clamp, paralysis, fracture, or inpatients
6) double or more cancers
7) other active cancer treatment
8) steroids or immunosuppressants
9) anybody assessed as inappropriate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosiyuki YAMAGUCHI
Organization Kawasaki Medical School
Division name Department of Clinical Oncology
Zip code
Address Matsushima 577, Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Email kasco@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosiyuki YAMAGUCHI
Organization Kawasaki Medical School
Division name Department of Clinical Oncology
Zip code
Address Matsushima 577, Kurashiki-city
TEL 086-462-1111
Homepage URL http://www.kawasaki-m.ac.jp/kasco/
Email kasco@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Clinical Oncology, Kawasaki Medical School
Institute
Department

Funding Source
Organization Department of Clinical Oncology, Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
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
2012 Year 11 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 Terminated
Date of protocol fixation
2012 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 Day
Last follow-up date
2016 Year 12 Month 09 Day
Date of closure to data entry
2016 Year 12 Month 09 Day
Date trial data considered complete
2016 Year 12 Month 09 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 23 Day
Last modified on
2017 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010756

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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