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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000792
Receipt No. R000000947
Scientific Title Phase II study of gemcitabine/S-1 combination therapy in patients with non-resectable advanced biliary tract cancer
Date of disclosure of the study information 2007/08/08
Last modified on 2010/10/25

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Basic information
Public title Phase II study of gemcitabine/S-1 combination therapy in patients with non-resectable advanced biliary tract cancer
Acronym Phase II study of gemcitabine/S-1 combination therapy in patients with non-resectable advanced biliary tract cancer
Scientific Title Phase II study of gemcitabine/S-1 combination therapy in patients with non-resectable advanced biliary tract cancer
Scientific Title:Acronym Phase II study of gemcitabine/S-1 combination therapy in patients with non-resectable advanced biliary tract cancer
Region
Japan

Condition
Condition non-resectable biliary tract cancer or recurrent biliary tract cancer post surgical treatment
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Our purpose is to evaluate the efficacy and safety of gemcitabine/S-1 combination therapy in patients with non-resectalbe advanced biliary tract cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Overall survival (OS)
Key secondary outcomes response rate (RR)
adverse events

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 Gemcitibine 1000 mg/m2 is infused in 30 min on day 1 and 8, and S-1 60 mg/m2 is given orally daily for 14 consecutive days. The cycle is repeated every 3 weeks until disease progression, unacceptable adverse events, patient withdrawal or death.
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. Patients with cytologically or histologically proved non-resectable biliary tract cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gall bladder cancer and ampulla vater cancer) or recurrent biliary tract cancer post surgical treatment
2. Patients of age >=20 years
3. Patients with PS of 0-2
4. Patients without the prior treatment except surgery
5. Patients with an adequate organ function
6. Patinets without other serious comorbid disease
7. Patients with an ability of oral intake
8. Patients with an estimated life expectancy of more than 3 months
9. Patients providing written informed consent
Key exclusion criteria 1. Patients with interstitial pneumonia or pulmonary fibrosis
2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months
3. Patients with severe active infection
4. Patients who are pregnant or lactating, or have an intention to get pregnant
5. Patients with a history of severe drug allery
6. Patients with other serious comorbid disease
7. Patinets with serious mental disease
8. Patients who are judged inappropriate for the entry into the study by the investigater
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Kanai
Organization Kyoto University Hospital
Division name Outpatient Oncology Unit
Zip code
Address 54 Syogoinn Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-4771
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University Hospital
Division name Outpatient Oncology Unit
Zip code
Address 54 Syogoinn Kawahara-cho, Sakyo-ku, Kyoto
TEL
Homepage URL
Email

Sponsor
Institute Kyoto University Hospital
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

Other administrative information
Date of disclosure of the study information
2007 Year 08 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2007 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2010 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2010 Year 03 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 08 Month 07 Day
Last modified on
2010 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000947

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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