UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter Randomized Phase II Study of consecutive-day versus alternate-day treatment with S-1 as Second-line chemotherapy in advanced pancreatic cancer.
Title of the study (Brief title)	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	Yoshiki Hirooka
Organization	Nagoya University Hospital
Division name	Department of Endoscopy
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	Yoshiki Hirooka
Organization	Nagoya University Hospital
Division name	Department of Endoscopy
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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