UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000792 |
|---|---|
| Receipt number | 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 09:29:12 |
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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
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
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000947
