UMIN-CTR Clinical Trial

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
Email	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
Email	kuriyama1012@yahoo.co.jp

Sponsor
Institute	Chigasaki Municipal Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007559