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


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 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


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

Value
https://center6.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