UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004922 |
|---|---|
| Receipt number | R000005856 |
| Scientific Title | Feasibility study of S-1 for adjuvant chemotherapy in Biliary-Pancreatic cancer |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2021/01/28 10:45:49 |
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Basic information
Public title
Feasibility study of S-1 for adjuvant chemotherapy in Biliary-Pancreatic cancer
Acronym
Feasibility study of S-1 for adjuvant chemotherapy in Biliary-Pancreatic cancer
Scientific Title
Feasibility study of S-1 for adjuvant chemotherapy in Biliary-Pancreatic cancer
Scientific Title:Acronym
Feasibility study of S-1 for adjuvant chemotherapy in Biliary-Pancreatic cancer
Region
| Japan |
Condition
Condition
Biliary-Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is evaluating the feasibility and safety of adjuvant chemotherapy of S-1 with 4-week administration followed by 2-week rest in Biliary-Pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility
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
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 after meals. The dosage of S-1 was 80mg/m2/day. S-1 is administred for 4 weeks followed by a 2-week rest. The administration of S-1 is continued 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)pathologically diagnosed biliary or pancreatic cancer
2)pathologically curative resection
3)stage2,3,4 in Japanese Classification of Biliary or Pancreatic Carcinoma
4)no cancerous ascites and diatal metastasis
5)good oral intake
6)PS 0 or 1 (ECOG)
7)no previous chemotherapy or radiation in 3 years
8)administration of S-1 within 10 weeks after surgery
9)preserved organ function (bone marrow, liver,and kidney)
Key exclusion criteria
1)previous treatment of S-1
2)recurrent case
3)fibroid lung or interstitial lung disease
4)active infectiou disease (excluding viral hepatitis)
5)sever complication
6)moderate ascites or pleural effusion
7)double cancer
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Uenishi |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepato-Biliary-Pancreatic Surgery
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
0666453841
m1297198@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroji |
| Middle name | |
| Last name | Shinkawa |
Organization
Osaka City University
Division name
Department of Hepato-Biliary-Pancreatic Surgery
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
+81666453841
Homepage URL
m1297198@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine,Department of Hepato-Biliary-Pancreatic Surgery
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine,Department of Hepato-Biliary-Pancreatic Surgery
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
Osaka City University
Address
1-2-7 Asahimachi, Abeno-ku, Osaka
Tel
06-6645-3456
ethics@med.osaka-cu.ac.jp
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
| 2013 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
1
Results
discontinuance
Results date posted
| 2021 | Year | 01 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
one patient with pancreatic cancer
Participant flow
patient undergoing surgery for pancreatic cancer
Adverse events
none
Outcome measures
survival time
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2010 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 01 | 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
| 2011 | Year | 01 | Month | 21 | Day |
Last modified on
| 2021 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005856
