UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical efficacy of novel cancer vaccines
Title of the study (Brief title)	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lung (NSCLC), esophageal, colorectal, gastric, gallbladder, or breast cancer 2) measurable lesions 3) HLA-A2402 4) withdrawn from previous treatments 5) Performance Status (P.S.) of 0-1 6) life expectancy of 3 months 7) preserved organ functions 8) written informed concent 9) no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	Yosiyuki YAMAGUCHI
Organization	Kawasaki Medical School
Division name	Department of Clinical Oncology
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	Yosiyuki YAMAGUCHI
Organization	Kawasaki Medical School
Division name	Department of Clinical Oncology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000010756