UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029421 |
|---|---|
| Receipt number | R000033623 |
| Scientific Title | Randomized phase 2 trial concerning the optimum schedule of S-1 adjuvant chemotherapy for resected biliary tract cancer (TOSBIC 03) |
| Date of disclosure of the study information | 2017/10/10 |
| Last modified on | 2019/11/12 10:16:04 |
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Basic information
Public title
Randomized phase 2 trial concerning the optimum schedule of S-1 adjuvant chemotherapy for resected biliary tract cancer (TOSBIC 03)
Acronym
Randomized phase 2 trial concerning the optimum schedule of S-1 adjuvant chemotherapy for resected biliary tract cancer (TOSBIC 03)
Scientific Title
Randomized phase 2 trial concerning the optimum schedule of S-1 adjuvant chemotherapy for resected biliary tract cancer (TOSBIC 03)
Scientific Title:Acronym
Randomized phase 2 trial concerning the optimum schedule of S-1 adjuvant chemotherapy for resected biliary tract cancer (TOSBIC 03)
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate the efficacy and feasibility of S-1 adjuvant therapy, which is administered orally for 6 months or 1 year for patients with curatively resected biliary tract cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
2-year disease free survival rate
Key secondary outcomes
relative dose intensity, treatment completed rate, adverse events, overall survival rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-1 adjuvant chemotherapy is conducted. S-1 80mg/m2/day is orally administered twice daily for 6 months. The 1 course of S-1 therapy is consist of 28 days administration followed by 14 days rest according to body surface area.
Interventions/Control_2
S-1 adjuvant chemotherapy is conducted. S-1 80mg/m2/day is orally administered twice daily for 1 year. The 1 course of S-1 therapy is consist of 28 days administration followed by 14 days rest according to body surface area.
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)intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer which histologically confirmed adenocarcinoma
2)patients with T2-4,N0,M0 or T1-4,N1,M0 of extrahepatic bile duct cancer and T1-4,N0-1,M0 of intrahepatic bile duct
cancer which is curatively resected(R0
or R1)
3)with no distant metastasis, cancerous ascites
4)age: >=20
5)ECOG P.S. 0-1
6)no prior treatment for biliary tract cancer except operation
7)no postoperative complications and possible to start treatment within 10 weeks from operation
8)sufficient function of important organs
WBC: >=3,500/mm3 and <=12,000/mm3
Neut:>=1500/mm3
Platelet: >=100,000/mm3
Hem: >=9.0g/dl
Alb:>=2.5g/dL
AST, ALT: <= 100IU/l((or 150U/L if biliary drainage were present)
sT.bil: <=2.0mg/dl
serum Cr: <=1.2mg/dL
Ccr: >=60 ml/min/body
9) oral intake
10)no abnormal finding by cardiac electrogram within 28 days
11)written informed consent
Key exclusion criteria
1)with history of TS-1 administration
2)with interstitial pneumonia or pulmonary fibrosis within 28 days before accrual
3)with diarrhea
4)with clinically important infection
5)blood infusion within 14 days before accrual
6)sever complication(heart failure, renal failure, liver failure, hemorrhagic peptic ulcer, intestinal paralysis, ileus, uncontrollable diabetes mellitus etc)
7)more than moderate degree of ascitic fluid and pleural effusion
8)has active carcinoma except carcinoma in situ
9)administered flucytosine, Phenytoin, Warfarin potassium
10) pregnant women or women who like be pregnant and willing to get pregnant, men who want his partner to be pregnant
11) known sever drug allergies
12) sever mental disorder
13) doctor's decision not to be registered to this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuta Abe |
Organization
Department of Surgery, Keio University School of Medicine
Division name
Division of General and Gastroenterological Surgery
Zip code
Address
Shinanomachi 35, shinjuku-ku
TEL
03-3353-1211
contact@keio-hbpts.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuta Abe |
Organization
Department of Surgery, Keio University School of Medicine
Division name
Division of General and Gastroenterological Surgery
Zip code
Address
Shinanomachi 35, shinjuku-ku
TEL
03-3353-1211
Homepage URL
http://www.keio-hpbts.jp/
contact@keio-hbpts.jp
Sponsor or person
Institute
Department of Surgery, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2017 | Year | 10 | Month | 10 | 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
| 2017 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 04 | Day |
Last modified on
| 2019 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033623
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| Registered date | File name |
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