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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014683
Receipt No. R000017003
Scientific Title Phase II study of chemoradiotherapy with S-1 plus cisplatin for clinical stage IA esophageal cancer (definitive chemoradiotherapy)
Date of disclosure of the study information 2014/07/30
Last modified on 2017/08/08

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

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of concurrent chemoradiotherapy with S-1 plus cisplatin 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 Complete response rate
Key secondary outcomes Overall survival, Progression free survival, 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 S-1 and cisplatin
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven squamous cell carcinoma, adenosquamous cell carcinoma or basaloid carcinoma of the esophagus
2) Primary lesion are located within the cervical esophagus (Ce) and the abdominal esophagus (Ae)
3) Aged 20 to 80 years old
4) ECOG PS of 0, 1 or 2
5) Clinical stage IA (cT1a or cT1bN0M0) or pT1 which need therapy
6) No need for measurable lesion
7) No previous treatment of esophageal cancer
8) Adequate food intake
9) No palsy of recurrent nerve
10) Adequate organ functions
11) Refused esophagectomy
12) Written informed consent
Key exclusion criteria 1) Simultaneous or metachronous double cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer
2) Patients requiring the administration of phenytoin or warfarin potassium
3) Uncontrollable diabetes millutus
4) History of myocardial infarction within 6 months, or unstable angina pectoris or cardiac failure
5) Uncontrollable arrhythmia
6) Patients requiring systemic steroids medication
7) Liver cirrhosis
8) Active bacterial or fungous infection
9) With a history of grade 2-4 allergic reaction by CTCAE version 4.0
10) With grade 2-4 nerve disturbance by CTCAE version 4.0
11) With blood transfusion within 2 weeks and/or active bleeding
12) Interstitial pneumonia, fibroid lung or severe emphysema
13) With a history of allergic reaction to tegafur (FT), gimestat (CDHP) and otastat potassium (Oxo)
14) Psychosis
15) Pregnant or lactating women, women of childbearing potential or men who like to have children in future
16) Any patients judged by the investigator to be unfit to participate in the study
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sachiko Yamamoto, MD
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 1-3-3, Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan
TEL 06-6972-1181
Email yamamoto-sa@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachiko Yamamoto, MD
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 1-3-3, Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan
TEL 06-6972-1181
Homepage URL
Email yamamoto-sa@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
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
Address
Tel
Email

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 地方独立行政法人大阪府立病院機構 大阪府立成人病センター

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 30 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 Open public recruiting
Date of protocol fixation
2014 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 28 Day
Last modified on
2017 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017003

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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