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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005918
Receipt No. R000006999
Scientific Title Phase 2 study of fix dose rate gemcitabine plus S-1 with advanced biliary tract cancer refractory to standard dose rate gemcitabine
Date of disclosure of the study information 2011/07/05
Last modified on 2017/07/10

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Basic information
Public title Phase 2 study of fix dose rate gemcitabine plus S-1 with advanced biliary tract cancer refractory to standard dose rate gemcitabine
Acronym Phase 2 study of fix dose rate GEM plus S-1 with advanced BTC refractory to GEM
Scientific Title Phase 2 study of fix dose rate gemcitabine plus S-1 with advanced biliary tract cancer refractory to standard dose rate gemcitabine
Scientific Title:Acronym Phase 2 study of fix dose rate GEM plus S-1 with advanced BTC refractory to GEM
Region
Japan

Condition
Condition Advanced biliary tract cancer refractory to standard rate gemcitabine
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objects of this study is to evaluate the efficacy and safety of fix dose rate gemcitabine plus S-1 with advanced biliary tract cancer refractory to standard rate gemcitabine.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Reponse rate
Key secondary outcomes Overall survival
Progression-free survival
Adverse events
Serious adverse events

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 Gemcitabine(1000mg/m2, div, over 100 minutes, day1), S-1(40mg/m2 twice daily, oral, day1-7), every two weeks. Treatment is repeated until disease progression, patient's refusal, or serious adverse event.
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

Not applicable
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 unrespectable 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) Measurable disease as defined by Revised RECIST guideline (version 1.1)
5) Without CNS metastasis
6) Without moderate or more ascites/pleural effusion
7) Refractoy to one prior gemcitabine or gemcitabine based chemotherapy, defined by RECIST version 1.1
8) No previous therapy against biliary tract cancer
9) No previous chemotherapy or radiotherapy against any other malignancies within 3 years
10) ECOG PS of 0, 1, 2
11) Sufficient oral intake
12) Aged 20 years old or over
13) At least 2 weeks have passed after the prior therapy
14) Adequate organ function
15) Written informed consent
Key exclusion criteria 1) Simultaneous or metachronous (within 3 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 or severe mental disorder
4) Patients requiring systemic steroids medication
5) Plumonary fibrosis or interstitial pneumonia
6) Uncontrollable watery diarrhea
7) Active bacterial or fungous infection
8) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, uncontrollable diabetes millitus etc
9) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium
10) Patients who can't receive neither iodic drug nor gadolinium because of drug allergy
11) Prior history of chemotherapy with pyrimidine fluoride for the other disease within the 5 years
12) Inadequate physical condition, as diagnosed by primary physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Ohkawa
Organization Kanagawa Cancer Center
Division name Division of Hepatobiliary and Pancreatic Oncology
Zip code
Address 2-3-2, Nakao, Asahi Ward, Yokohama
TEL 045-520-2222
Email s-ohk@kcch.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Kobayashi
Organization Kanagawa Cancer Center
Division name Division of Hepatobiliary and Pancreas Oncology
Zip code
Address 2-3-2, Nakao, Asahi Ward, Yokohama
TEL 045-391-5761
Homepage URL
Email kobayashis@kcch.jp

Sponsor
Institute Yokohama Clinical Oncology Group
Institute
Department

Funding Source
Organization None
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 神奈川県立がんセンター(神奈川県)
横浜市立大学付属市民総合医療センター(神奈川県)
国立国際医療研究センター(東京都)
国立がん研究センター中央病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://meetinglibrary.asco.org/content/157741-173
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 Main results already published
Date of protocol fixation
2011 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2015 Year 06 Month 30 Day
Date of closure to data entry
2016 Year 06 Month 01 Day
Date trial data considered complete
2016 Year 06 Month 01 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 07 Month 05 Day
Last modified on
2017 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006999

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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