UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase 3 study of gemcitabine and S-1 compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer.
Title of the study (Brief title)	A phase 3 study of GEM and S-1 compared with GEM for unresectable advanced 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	The aim of this study is to evaluate the efficacy of gemcitabine and S-1 compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	progression free survival
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1 60mg/m2/day is administered orally twice daily from the evening of day 1 to the morning of day 15 followed by a one week rest. Gemcitabine 1000mg/m2 was administered in a 30-min intravenous infusion on days 8 and 15 of each cycle. The cycle was repeated every 21 days until disease progression.
Interventions/Control_2	Gemcitabine 1000mg/m2 was administered in a 30min intravenous infusion on day 1, 8, 15. The cycle was repeated every 4 weeks until disease progression.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Histopathologically proven advanced pancreatic cancer (2)20 - 79 years of age, (3)ECOG PS 0 or 1 (4)No prior chemotherapy or radiotherapy (5)Oral intake is possible (6)Written informed consent (7)Adequate organ function
Key exclusion criteria	(1)severe concurrent disease, (2)interstitial pneumonia, (3)massive abdominal or pleural effision (4)mental disoeder, (5)active concomitant malignancy, (6)severe diarrhea, (7)brain metastasis, (8)severe drug hypersensitibity, (9)pregnant or lactating females, (10)regular use of phenytoin, warfarin or frucitocin, (11)inappropriate for entry onto the study, as diagnosed by primary physician.
Target sample size	100

Research contact person
Name of lead principal investigator	Taketo Yamaguchi
Organization	Chiba Cancer Center
Division name	Gastroenterology
Address	666-2, Nitona-cho, Chuo-ku, Chiba
TEL
Email

Public contact
Name of contact person	Kentaro Sudo
Organization	Chiba Cancer Center
Division name	Gastroenterology
Address
TEL
Homepage URL
Email	kesudou-gi@umin.ac.jp

Sponsor
Institute	Chiba Cancer Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2009 Year 07 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 10 Month 31 Day
Anticipated trial start date	2007 Year 11 Month 01 Day
Last follow-up date	2012 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 07 Month 23 Day
Last modified on	2016 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002599