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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004886
Receipt No. R000005816
Scientific Title PhaseI/II study of WT1 peptide vaccination plus gemcitabine and cisplatin versus gemcitabine and cisplatin in advanced biliary tract cancer
Date of disclosure of the study information 2011/01/18
Last modified on 2015/01/18

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Basic information
Public title PhaseI/II study of WT1 peptide vaccination plus gemcitabine and cisplatin versus gemcitabine and cisplatin in advanced biliary tract cancer
Acronym WT-BT trial
Scientific Title PhaseI/II study of WT1 peptide vaccination plus gemcitabine and cisplatin versus gemcitabine and cisplatin in advanced biliary tract cancer
Scientific Title:Acronym WT-BT trial
Region
Japan

Condition
Condition advanced biliary tract cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate safety and efficacy of WT1 peptide vaccination plus gemcitabine and cisplatin versus gemcitabine and cisplatin as a first-line treatment for advanced biliary tract cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes 1-year survival
Key secondary outcomes progression-free survival, response rate, overall survival, 2-year survival, adverse events, severe adverse events, vaccination biomarker

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine+cisplatin+WT1 peptide vaccination
gemcitabine : 1,000mg/m2, day1, 8, q21
cisplatin : 25mg/m2, day1, 8, q21
WT1 vaccination : 0.4ml x2, ay1, 8, q21
Interventions/Control_2 Gemcitabine+cisplatin
gemcitabine : 1,000mg/m2, day1, 8, q21
cisplatin : 25mg/m2, day1, 8, q21
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) Diagnosed as biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer
2) Recurrent or unresectable biliary tract cancer
3) Histologically proven papillary adenocarcinoma, tubular adenocarcinoma, or adenosquamous carcinoma for extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer patients. Histologically proven adenocarcinoma for intrahepatic cholangiocarcinoma
4) Without CNS metastasis
5) Without moderate or more ascites/pleural effusion
6) No previous therapy against biliary tract cancer
7) No previous operation, chemotherapy or radiotherapy and no reccurence against any other malignancies within 5 years
8) No previous chemotherapy of gemcitabine or cisplatin against any other malignancies
9) ECOG PS of 0 or 1
10) Sufficient oral intake
11) Aged 20 to 80 years old
12) Adequate organ functions
13) HLA of A2402, A0201 or A0206
14) Written informed consent








Key exclusion criteria 1) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy
2) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant
3) Psychosis
4) Patients requiring systemic steroids medication
5) Interstitial pneumonia or fibroid lung
6) Active bacterial or fungous infection
7) Severe complication
8) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy
9) Inadequate physical condition, as diagnosed by primary physician










Target sample size 106

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuji Okusaka
Organization National Cancer Center Hospital
Division name Hepatobiliary and Pancreatic Oncology Division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ueno
Organization Kanagawa Cancer Center
Division name Division of Hepatobiliary and Pancreatic Medical Oncology
Zip code
Address 1-1-2 Nakao Asahi-ku Yokohama City, Japan 241-0815
TEL 045-391-5761
Homepage URL
Email kantansui@kcch.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization JAPAN

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
2011 Year 01 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 Terminated
Date of protocol fixation
2010 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2011 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
2011 Year 01 Month 17 Day
Last modified on
2015 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005816

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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