UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009695 |
|---|---|
| Receipt number | R000011366 |
| Scientific Title | Multicenter Randomized Phase II Study of consecutive-day versus alternate-day treatment with S-1 as Second-line chemotherapy in advanced pancreatic cancer. |
| Date of disclosure of the study information | 2013/01/04 |
| Last modified on | 2017/10/31 21:27:36 |
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Basic information
Public title
Multicenter Randomized Phase II Study of consecutive-day versus alternate-day treatment with S-1 as Second-line chemotherapy in advanced pancreatic cancer.
Acronym
Multicenter Randomized Phase II Study of consecutive-day versus alternate-day treatment with S-1 as Second-line chemotherapy in advanced pancreatic cancer. (SCOTCH)
Scientific Title
Multicenter Randomized Phase II Study of consecutive-day versus alternate-day treatment with S-1 as Second-line chemotherapy in advanced pancreatic cancer.
Scientific Title:Acronym
Multicenter Randomized Phase II Study of consecutive-day versus alternate-day treatment with S-1 as Second-line chemotherapy in advanced pancreatic cancer. (SCOTCH)
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
efficacy
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival time
Key secondary outcomes
QOL,Progression-free survival,Time to treatment failure,Response rate,
Frequency and severity of adverse events,
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
anti-cancer drug
Interventions/Control_2
anti-cancer drug
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
The study is designed to enroll patients with unresectable,pathologically proven,pancreatic cancer.All patients is received initial treatment that includes an anti-cancer agent S-1 + other or other non S-1 for unresectable advanced pancreatic cancer.Other eligibility criteria includes performance status of 0-2,cases can be taken orally.Written informed consent is required from all patients.
Key exclusion criteria
The exclusion criteria are as follows active infection.Pregnant or lactating women,women of childbearging age.The patient inappropriate for entry onto this study in the judgment of the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65,Tsuruma-Cho,Showa-Ku,Nagoya City
TEL
052-744-2602
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65,Tsuruma-Cho,Showa-Ku,Nagoya City
TEL
052-744-2602
Homepage URL
jur16@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | 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
| 2012 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 10 | 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
| 2013 | Year | 01 | Month | 04 | Day |
Last modified on
| 2017 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011366
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
