UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA esophageal cancer (definitive chemoradiotherapy)
Acronym	Phase II study of chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA esophageal cancer
Scientific Title	Phase II study of chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA esophageal cancer (definitive chemoradiotherapy)
Scientific Title:Acronym	Phase II study of chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA esophageal cancer
Region	Japan

Condition
Condition	esophageal cancer (clinical stage IA)
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of concurrent chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA (UICC-TNM ver.7.0) esophageal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Overall survival, Complete Response Rate, Preservation rate, Relative dose intensity, Adverse event

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Concurrent chemoradiotherapy with 5-FU and cisplatin followed by S-1
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) Clinical stage IA (cT1a or cT1bN0M0)esophageal cancer (Histologically proven squamous cell carcinoma of the esophagus) 2) Aged >= 20 years old 3) ECOG PS of 0 or 1 4) Adequate food intake 5) No esophageal cancer including HGIN out of radiation field 6) Adequate organ functions 7) Written informed consent
Key exclusion criteria	1) Previous treatment with pyrimidine fluoride drug or platinum within 5 years 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 or platinum 5) Active infection 6) Positive HBs antigen 7) Previous radiotherapy to chest 8) With severe diarrhea 9) Psychosis 10) Pregnant or lactating women, women of childbearing potential or women who like to have children in future 11) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium 12) Any patients judged by the investigator to be unfit to participate in the study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tetsuo Middle name Last name Takehara
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	565-0871
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	1st name Yoshito Middle name Last name Hayashi
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	565-0871
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	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
Tel	06-6879-5111
Email	rinri@hp-crc.med.osaka-u.ac.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

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 15 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	No longer recruiting
Date of protocol fixation	2014 Year 10 Month 24 Day
Date of IRB	2014 Year 10 Month 24 Day
Anticipated trial start date	2014 Year 12 Month 16 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 12 Month 14 Day
Last modified on	2021 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018547