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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014752
Receipt No. 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

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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
Email 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
Email contact@keio-hpbts.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017026

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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