UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001614 |
|---|---|
| Receipt number | R000001917 |
| Scientific Title | Multicenter phase II study of second-line S-1 monotherapy in patients with gemcitabine-refractory advanced biliary tract cancer |
| Date of disclosure of the study information | 2009/01/03 |
| Last modified on | 2010/10/02 15:56:03 |
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Basic information
Public title
Multicenter phase II study of second-line S-1 monotherapy in patients with gemcitabine-refractory advanced biliary tract cancer
Acronym
Phase II study of S-1 monotherapy in patients with gemcitabine-refractory advanced biliary tract cancer
Scientific Title
Multicenter phase II study of second-line S-1 monotherapy in patients with gemcitabine-refractory advanced biliary tract cancer
Scientific Title:Acronym
Phase II study of S-1 monotherapy in patients with gemcitabine-refractory advanced biliary tract cancer
Region
| Japan |
Condition
Condition
Gemcitabine-refractory advanced biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of S-1 monotherapy for gemcitabine-refractory advanced biliary tract cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
Time to progression, Overall survival, Toxicity
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
S-1 was administered orally for 28 days, followed by 14 days rest (one cycle)until disease progression.
Dose of S-1:
<1.25m2 80mg/day
1.25m2-1.5m2 100mg/day
>1.5m2 120mg/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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with non-resectable or post-operative recurrent biliary tract cancer
2) Patients with pathologically proven or graphically confirmed biliary tract cancer
3) Patients with gemcitabine-refractory advanced biliary tract cancer
4) Patients with one or more bidimentionally measurable lesions
5) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2
6) Patients of age >= 20 years
7) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal, and creatinine clearance >= 50ml/min.
8) Patients have an ability for a sufficient oral intake
9) Written informed consent is required from all patients.
Key exclusion criteria
1) Patients with an active concomitant infection
2) Patients with digestive ulcer or gastrointestinal bleeding
3) Patients with severe cardiovascular or renal disease
4) Patients with uncontrollable massive pleural effusion or massive ascites
5) Patients with an active concomitant malignancy
6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception
7) Patients with a previous history of a severe drug hypersensitivity
8) Patients receiving anti-cancer drugs
9) Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
Faculty of Medicine, University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Sasaki |
Organization
Faculty of Medicine, University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
Sponsor or person
Institute
Faculty of Medicine, University of Tokyo
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
| 2009 | Year | 01 | Month | 03 | 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 | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 03 | Day |
Last modified on
| 2010 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001917
