UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004886 |
|---|---|
| Receipt number | 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 03:27:21 |
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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
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
kantansui@kcch.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005816
