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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009695
Receipt No. 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

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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
Email 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
Email jur16@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

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
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 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
URL(English) https://upload.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
Registered date File name


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