UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021459 |
|---|---|
| Receipt number | R000024745 |
| Scientific Title | Phase II study of adjuvant therapy of alternate day oral therapy with S-1 for patients with curative resected biliary tract cancer |
| Date of disclosure of the study information | 2016/03/25 |
| Last modified on | 2016/03/13 02:06:29 |
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Basic information
Public title
Phase II study of adjuvant therapy of alternate day oral therapy with S-1 for patients with curative resected biliary tract cancer
Acronym
Phase II study of adjuvant therapy of alternate day oral therapy with S-1 for patients with curative resected biliary tract cancer
Scientific Title
Phase II study of adjuvant therapy of alternate day oral therapy with S-1 for patients with curative resected biliary tract cancer
Scientific Title:Acronym
Phase II study of adjuvant therapy of alternate day oral therapy with S-1 for patients with curative resected biliary tract cancer
Region
| Japan |
Condition
Condition
biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Improvement of overall survival
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
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
Historical
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 80mg/m2/day is orally administered twice a day for adjuvant therapy. This therapy is administerd alternate day for 1 year.
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)intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer which is pathologically proven diagnosis of adenocarcinoma.
2) Biliary tract cancer which is curatively resected(R0 or R1)
3)with no distant metastasis, cancerous ascites
4) Age of more than 20 years
5) ECOG performance status (PS) of 0 to 1
6) No therapy without surgery for biliary tract cancer
7) No postoperative complications and possible to start treatment within 10 weeks from operation
8) Adequate organ function
WBC: >=2,500/mm3 and <=12,000/mm3
Neut:>=1,500/mm3
Platelet: >=100,000/mm3
sT.bil: <=2.0mg/dl
AST, ALT: <= 100IU/L
Cre <= 1.2mg/dL
9) oral intake
10)written informed consent
Key exclusion criteria
1) administration contraindication of TS-1
2)Regular use of frucitocin, fenitoin, warfarin
3) Severe infection
4) Intestinal pneumonia or lung fibrosis
5) Severe diarrhea
6) Severe complication
7) History of other active malignancy
8) Pregnancy or the desire to preserve fecundity
9) Inadequate physical condition, as diagnosed by primary physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiko Tsuchida |
Organization
Tokyo Medical University
Division name
gastrointestinal and pediatric surgery
Zip code
Address
6-7-1 Nish-Shinjyuku Shinjyuku Tokyo
TEL
03-3342-6111
akibobo@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Nagakawa |
Organization
Tokyo Medical University
Division name
gastrointestinal and pediatric surgery
Zip code
Address
6-7-1 Nish-Shinjyuku Shinjyuku Tokyo
TEL
03-3342-6111
Homepage URL
naga@tokyo-med.ac.jp
Sponsor or person
Institute
Gastrointestinal and pediatric surgery
Tokyo medical university
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
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
| 2016 | Year | 03 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 25 | 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
| 2016 | Year | 03 | Month | 13 | Day |
Last modified on
| 2016 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024745
