UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments
Title of the study (Brief title)	Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To explore the efficacy and the safety of S-1 therapy for esophageal cancer resistant or intolerable existing treatments
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	progression free survival
Key secondary outcomes

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 treatment (day1-28)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) advanced or recurrent esophageal cancer proven histologically 2) aged >= 20 years old 3) ECOG PS of 0, 1 or 2 4) resistant or intolerable existing treatments 5) adequate food intake 6) with measurable lesions 7) Adequate organ functions 8) Written informed consent
Key exclusion criteria	1) Previous treatment with S-1 2) With active diseases (interstitial pneumonia, fibroid lung, intestinal obstruction, uncontrollable diabetes millutus or hypertentsion, history of myocardial infarction within 6 months, or unstable angina pectoris, liver cirrhosis, renal failure) 3) Simultaneous or metachronous cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer 4) History of severe allergic reactions to pyrimidine fluoride drug 5) Active infection 6) With severe diarrhea 7) With symptomatic metastasis to nerve 8) Psychosis 9) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium 10) Pregnant or lactating women, women of childbearing potential or women who like to have children in future 11) Participant to other clinical trials 12) Any patients judged by the investigator to be unfit to participate in the study
Target sample size	50

Research contact person
Name of lead principal investigator	Tetsuo Takehara
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	06-6879-5111
Email	takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	Yoshito Hayashi
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	06-6879-5111
Homepage URL
Email	y.hayashi@gh.med.osaka-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
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	2016 Year 08 Month 26 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 08 Month 23 Day
Anticipated trial start date	2016 Year 08 Month 26 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	2016 Year 08 Month 23 Day
Last modified on	2018 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027338