UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001595 |
|---|---|
| Receipt number | R000001908 |
| Scientific Title | Randomized phase II study comparing Gemcitabine versus TS-1 for advanced bile duct cancer |
| Date of disclosure of the study information | 2008/12/22 |
| Last modified on | 2019/04/08 13:00:45 |
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Basic information
Public title
Randomized phase II study comparing Gemcitabine versus TS-1 for advanced bile duct cancer
Acronym
Randomized phase II study comparing GEM versus TS-1 for advanced bile duct cancer
Scientific Title
Randomized phase II study comparing Gemcitabine versus TS-1 for advanced bile duct cancer
Scientific Title:Acronym
Randomized phase II study comparing GEM versus TS-1 for advanced bile duct cancer
Region
| Japan |
Condition
Condition
Advanced bile duct cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical effectiveness of TS-1 comparing Gemcitabine for advanced bile duct cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival(OS)
Key secondary outcomes
Progression free survival(PFS)
Adverse events
QOL
Response rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A:Gemcitabine 1,000mg/m2 is administered with 30-min intravenous infusion on day 1, 8, and 15 every 4 weeks.
Interventions/Control_2
Group B:TS-1 80mg/m2/day is administered orally for 4 consecutive weeks every 6 weeks.
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.Patients with non-resectable bile duct cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gall bladder cancer and ampulla vater cancer) or recurrent bile duct cancer
2.Histologically or cytologically confirmed adenocarcinoma,squamous cell carcinoma or adeosquamous carcinoma of the bile duct cancer(extrahepatic bile duct cancer, gall bladder cancer and ampulla vater cancer).
Histologically or cytologically confirmed adenocarcinoma of the intrahepatic bile duct cancer.
3.Patients without the prior treatment except surgery and biliary drainage
4.Patients who received adjuvant chemotherapy 6 months or more ago can be registered.
5.Performance Status:0-1(ECOG)
6.Oral intake is possible.
7.Patients of age =>20 and 80>
8.Sufficient organ functions
(1)hemoglobin>=10.0g/dl
(2)WBC >=3,000/mm3
(3)neutrophils>=1,500/mm3
(4)platelets>=100,000/mm3
(5)AST(GOT)<=100IU (or <=150IU if biliary drainage were present)
(6)ALT(GPT)<=100IU (or <=150IU if biliary drainage were present)
(7)total bilirubin <=2.0mg/dl,(or <=3.0mg/dl if biliary drainage were present)
(8)serum creatinine <= 1.2mg/dl
(9)creatinine clearance>=60ml/min
9.Written informed consent
Key exclusion criteria
1.lung fibrosis or intestinal pneumonia
2.Watery diarrhea
3.Severe infection
4.Severe complication
(heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)
5.Medical history of serious allergy reactions to any drug
6.Massive pleural or abdominal effusion
7.Metastasis to central nervous system
8.Active synchronous or metachronous malignancy other than carcinoma in situ
9.Regular use of frucitocin, fenitoin or warfarin
10.Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
11.Severe mental illness
12.Patients who are judged inappropriate for the entry into the study by the investigater
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ioka |
Organization
Osaka International Cancer Institute
Division name
Department of Hepatobiliary and pancreatic Oncology
Zip code
Address
3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL
06-6945-1181
ioka_ta@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ioka |
Organization
Osaka International Cancer Institute
Division name
Department of Hepatobiliary and pancreatic Oncology
Zip code
Address
3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL
06-6945-1181
Homepage URL
ioka_ta@hotmail.com
Sponsor or person
Institute
Osaka International Cancer Institute
Department of Hepatobiliary and pancreatic Oncology
Institute
Department
Personal name
Funding Source
Organization
Osaka foundation for the prevention of cancer and cardiovascular diseases
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2008 | Year | 12 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2008 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 22 | Day |
Last modified on
| 2019 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001908
