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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001294
Receipt No. R000001564
Scientific Title Two institutional trial to evaluate the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer
Date of disclosure of the study information 2008/08/08
Last modified on 2015/11/25

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Basic information
Public title Two institutional trial to evaluate the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer
Acronym Evaluation of the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer
Scientific Title Two institutional trial to evaluate the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer
Scientific Title:Acronym Evaluation of the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer
Region
Japan

Condition
Condition Biriary tract cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Feasibility
Key secondary outcomes Efficacy

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
Interventions/Control_1 Administration of gemcitabine and cisplatin for adjuvant chemotherapy
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 Histologically proven biliary tract cancer after surgical resection
Stage IB,IIA, IIB,III (UICC)
R0 and R1
No previous chemo- or radiotherapy within 3 years
Within 8 weeks after operation
PS 0 and 1
Hb >=10g/dl
WBC >=3000/mm3
Neutrophil >=1500/mm3
Platelet >=100,000/mm3
AST, ALT <=150U/L
T-Bil <=3mg/dl
CCr >=45ml/min
Key exclusion criteria Apparent infection
Fever
Heart disease
Interstitial pneumonia, pulmonary fibrosis
Other active cancers
Brain metastasis
Pericardial effusion
Allergy of the drugs
Pregnancy or patient's hope to be pregnant
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehide Asano
Organization National Hospital Organization Chiba-East-Hospital
Division name Department of Surgery
Zip code
Address 673 Nitona, Chuo-ku, Chiba, Japan
TEL 043-261-5171
Email asano@cehpnet.com

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Kainuma
Organization Chiba Cancer Center
Division name Gastroenterological Surgery
Zip code
Address 666-2 Nitona, Chuo-ku, Chiba, Japan
TEL 043-264-5431
Homepage URL
Email okainuma@chiba-cc.jp

Sponsor
Institute Chiba Cancer Center
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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 帝京大学病院(東京都)、千葉県がんセンター(千葉県)、東海大学病院(神奈川県)、千葉東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2008 Year 08 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1868-6982
Number of participants that the trial has enrolled
Results Among 29 evaluable patients, the protocol was completed in 21 (72%) patients. Relative dose intensity (RDI) of gemcitabine and CDDP was 77% and 81%, respectively. There was no difference in the completion rate and the RDI between patients who underwent resection with vs. without major hepatectomy. Grade 3-4 toxicities included leukopenia
(14%) and neutropenia (27%). Two-year RFS and 2-year OS was 59% and 90%, respectively.
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 Completed
Date of protocol fixation
2007 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2014 Year 10 Month 31 Day
Date of closure to data entry
2014 Year 11 Month 30 Day
Date trial data considered complete
2014 Year 11 Month 30 Day
Date analysis concluded
2014 Year 12 Month 28 Day

Other
Other related information

Management information
Registered date
2008 Year 08 Month 04 Day
Last modified on
2015 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001564

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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