UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014752 |
|---|---|
| Receipt number | R000017026 |
| Scientific Title | Feasibility study of alternate day oral tyerapy with TS-1 in patients with resected pancreatic cancer or biliry tract cancer |
| Date of disclosure of the study information | 2014/08/04 |
| Last modified on | 2017/10/14 19:35:05 |
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Basic information
Public title
Feasibility study of alternate day oral tyerapy with TS-1 in patients with resected pancreatic cancer or biliry tract cancer
Acronym
Feasibility study of alternate day oral tyerapy with TS-1 in patients with resected pancreatic cancer or biliry tract cancer
Scientific Title
Feasibility study of alternate day oral tyerapy with TS-1 in patients with resected pancreatic cancer or biliry tract cancer
Scientific Title:Acronym
Feasibility study of alternate day oral tyerapy with TS-1 in patients with resected pancreatic cancer or biliry tract cancer
Region
| Japan |
Condition
Condition
pancreatic cancer or 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 feasibility of TS-1 adjuvant therapy, which is administered orally alternate day for 1 year for patients with curatively resected pancreatic cancer or biliary tract cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Treatment completed rate
Key secondary outcomes
Overall survival
Relapse-free survival
Adverse events
Time to treatment failure
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 adjuvant chemotherapy is conducted. S-1 80mg/m2/day is orally administered twice daily every monday, wednesday,friday and sunday 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
<pancreatic cancer>
1)pancreatic cancer which is curatively resected(R0 or R1)
2)patients without Stage IVb pancreatic cancer
<biliary tract cancer>
1)intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer which is curatively resected(R0 or R1)
2)patients without Stage Ia nor Stage IVb biliary tract cancer
<pancreatic cancer and biliary tract cancer>
3)with no distant metastasis, cancerous ascites
4)age: >=20
5)No postoperative complications and possible to start treatment within 12 weeks from operation
6)sufficient function of important organs
WBC: >=2,000/mm3 and <=12,000/mm3
Neut:>=1,500/mm3
Platelet: >=75,000/mm3
Hem: >=8.0g/dl
sT.bil: <=3.0mg/dl
AST, ALT: <= 150IU/L
Ccr: >=30 ml/min/body
7) oral intake
8)written informed consent
*ECOG P.S.:anything is OK
Key exclusion criteria
1) administration contraindication of TS-1
2)with recurrence before the entry of this study
3)with clinically important infection
4)with sever heart failure
5)with interstitial pneumonia or pulmonary fibrosis
6)with sever complication(Intestinal paralysis, Ileus, uncontrollable diabetes mellitus, Renal failure, Liver failure etc)
7)massive ascites fluid or pleural effusion
8)repetitive blood infusion for gastrointestinal hemorrhage or blood infusion within 14 days before accrual
9)with mental disorder receving treatment or needing treatment
10)has active carcinoma except carcinoma in situ
11) administered Flucytosine, Phenytoin, Warfarin potassium
12)pregnant women or lactating women or women who like be pregnant and willing to get pregnant, men who want his partner to be pregnant
13) doctor's decision not to be registered to this study
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Itano |
Organization
Department of Surgery, Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-3353-1211
contact@keio-hpbts.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Kitago |
Organization
Department of Surgery, Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
contact@keio-hpbts.jp
Sponsor or person
Institute
Keio University School of Medicine
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
慶応義塾大学病院（東京都）、川崎市立井田病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 04 | 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 03 | Day |
Last modified on
| 2017 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017026
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