UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of induction chemotherapy with gemcitabine and S-1 followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Title of the study (Brief title)	Phase II study of induction chemotherapy with gemcitabine and S-1 followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Region	Japan

Condition
Condition	locally advanced pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This phase II study was designed to assess the efficacy and safety of induction chemotherapy with gemcitabine and S-1 followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1-year survival rate
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	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	Induction GS: S-1 60/80/100 mg/day based on BSA, from the evening of day 1 to the morning of day 15, q3w, GEM 1000 mg/m2, day8 and 15 S-1+RT: S-1 80/100/120 mg/day based on BSA, day1-14 and 22-35 RT 1.8Gy/day, 28fractions, total 50.4Gy Maintenance chemotherapy with S-1: S-1 80/100/120 mg/day based on BSA, day1-14, q3w
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

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)Histologically or cytologically proven adenocarcinoma (2)unresectable locally advanced pancreatic cancer without distant metastases (3)no evidence of gastroduodenal invasion or obstruction (4)ECOG PS 0 or 1 (5)No prior chemotherapy or radiotherapy (6)Written informed consent (7)Adequate organ function
Key exclusion criteria	(1)severe concurrent disease (2)interstitial pneumonia, severe pulmonary emphysema or active pnemonia (3)mental disorder (4)active concomitant malignancy (5)moderate or severe diarrhea, hemorrhagic colitis or peptic ulcer (6)severe drug hypersensitibity (7)pregnant or lactating females (8)regular use of phenytoin, warfarin or frucitocin (9)Under treatment with systemic steroid (10)fever of 38 degrees centigrade or higher, or infection requiring systemic treatment (11)inappropriate for entry onto the study, as diagnosed by primary physician
Target sample size	30

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, Chiba pref, Japan
TEL
Email

Public contact
Name of contact person
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	2011 Year 09 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 10 Day
Anticipated trial start date	2011 Year 09 Month 28 Day
Last follow-up date
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	2011 Year 09 Month 12 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=R000007484