UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006369 |
|---|---|
| Receipt number | R000007559 |
| Scientific Title | Phase II study of S-1 for elderly patients with unresectable pancreatic cancer |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2022/09/27 14:21:40 |
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Basic information
Public title
Phase II study of S-1 for elderly patients with unresectable pancreatic cancer
Acronym
Phase II study of S-1 for elderly patients with unresectable pancreatic cancer
Scientific Title
Phase II study of S-1 for elderly patients with unresectable pancreatic cancer
Scientific Title:Acronym
Phase II study of S-1 for elderly patients with unresectable pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of S-1 for unresectable pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Safety, overall survival, progression-free survival
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 is orally administered on days 1-28 of a 42-day cycle. Administration dose of S-1 is based BSA : BSA<1.25m2, 40mg twice daily; 1.25-1.5m2, 50mg twice daily; >=1.5m2, 60mg twice daily.
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
| 70 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) written informed consent
2) oral intake is possible
3) histologically proven pancreatic ductal carcinoma
4) age: >=70 and =<90
5) no previous treatment (chemotherapy) for pancreatic cancer
6) presence of measurable lesion
7) adequate hematologic, hepatic, renal, and cardiac function
8) Karnofsky Performance status: >=50
9) expected more than 8 weeks survival
Key exclusion criteria
1) severe diarrhea
2) require administration of flucytosine, phenytoin, and warfarin
3) severe pleural effusion, ascites fluid
4) active infection
5) active double cancer
6) active peptic ulcer
7) severe comorbidity (cardiovascular disease, renal disease, liver disease, Intestinal tract paralysis)
8) severe mental disorder
9) drug hypersensitivity
10) possibility of pregnancy or patient's hope to be pregnant
11) doctor's decision not to be registered to this study
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kuriyama |
Organization
Chigasaki Municipal Hospital
Division name
Department of Gastroenterology
Zip code
253-0042
Address
5-15-1, Honson, Chigasaki
TEL
0467-52-1111
kuriyama1012@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kuriyama |
Organization
Chigasaki Municipal Hospital
Division name
Department of Gastroenterology
Zip code
253-0042
Address
5-15-1, Honson, Chigasaki
TEL
0467-52-1111
Homepage URL
kuriyama1012@yahoo.co.jp
Sponsor or person
Institute
Chigasaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chigasaki Municipal Hospital
Address
5-15-1, Honson, Chigasaki
Tel
0467521111
hosp_soumu@city.chigasaki.kanagawa.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
茅ヶ崎市立病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 01 | 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
| 2007 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2007 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 19 | Day |
Last modified on
| 2022 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007559
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