UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016913 |
|---|---|
| Receipt number | 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 09:47:01 |
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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
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
uwatadashi@msn.com
Sponsor or person
Institute
Jikei University school of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019630
