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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016913
Receipt No. R000019630
Scientific Title Phase II trial of gemcitabine/cisplatin/s1 for inoperable biliary tract cancer
Date of disclosure of the study information 2015/04/01
Last modified on 2019/03/28

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Basic information
Public title Phase II trial of gemcitabine/cisplatin/s1 for inoperable biliary tract cancer
Acronym Chemotherapy for the patients with inoperable biriary tract cancer
Scientific Title Phase II trial of gemcitabine/cisplatin/s1 for inoperable biliary tract cancer
Scientific Title:Acronym Chemotherapy for the patients with inoperable biriary tract cancer
Region
Japan

Condition
Condition Birialy tract cancer
Classification by specialty
Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of gemcitabine/cisplatin/s1 therapy for inoperable biliary tract cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival, Response rate, Disease control rate, one-year survival rate, Tumor marker
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine is i.v. administered at a dose of 1000 mg/m2 for 30 min on days 1,8 of each 21-day cycle.
Cisplatin is i.v. administered at a dose of 25 mg/m2 for 120 min on days 1,8 of each 21-day cycle.
TS-1 is administered orally 2 consecutive weeks every 3 weeks.
TS-1 is administered orally on alternate days from day1.

Dose of TS-1 per day
BSA
<1.25 m2 80 mg/day
1.25-1.5 m2 100 mg/day
>=1.5 m2 120 mg/day
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 1)The patients with inoperable advanced biliary tract cancer including intrahepatic cholangiocarcinoma and ampullary carcinoma diagnosed by pathologically methods or graphically visualizes examination Patients with post-operative recurrent is excluded)
2)Patients of age =>20 and 80>
3)Patientswith Eastern Chemotherapy Oncology Group (ECOG) performance status of 0,1
4)Life expectancy more than 3 months
5)Hemoglobin >=9.0g/dl,
WBC>=3,000/mm3,12,000/mm3,
neutrophils >=1,500/mm3, platelets >=100,000/mm3,
AST/ALT </=100,
Total bilirubin </=2.0 x ULN,
Serum creatinine </=1.0 x ULN,
BUN </=1.0 x ULN,
PaO2 >= 70 torr
Creatinine clearance>=60 ml/min
6)No other treatments, such as radiation or chemotherapy
7)Written informed consent
Key exclusion criteria 1)Pulmonary fibrosis or interstitial pneumonia detectable on chest X-ray
2)Active infection
3)Uncontrollable heart disease and myocardial infarction within 6 months
4)Uncontrollable DM
5)Pregnant or lactation women, or women with known or suspected pregnancy
6)History of severe drug allergy
7)Active synchronous or metachronous malignancy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Katsuhiko
Middle name
Last name Yanaga
Organization Jikei University school of Medicine
Division name Department of surgery, Division of hepatobiliary pancreatic surgery
Zip code 105-8461
Address 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Email kyanaga@jikei.ac.jp

Public contact
Name of contact person
1st name Tadashi
Middle name
Last name Uwagawa
Organization Jikei University school of Medicine
Division name Department of surgery, Division of hepatobiliary pancreatic surgery
Zip code 105-8461
Address 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Homepage URL
Email uwatadashi@msn.com

Sponsor
Institute Jikei University school of Medicine
Institute
Department

Funding Source
Organization Jikei University school of Medicine
Department of surgery
Division of hepatobiliary pancreatic surgery
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 Jikei University school of Medicine IRB
Address 3-19-18 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
Tel 03-3433-1111
Email rinri@jikei.ac.jp

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
2015 Year 04 Month 01 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 Open public recruiting
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 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
2015 Year 03 Month 25 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019630

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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