UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II trial of concurrent chemoradiotherapy with 5-FU plus cisplatin for resectable squamous cell carcinoma of cervical esophagus
Title of the study (Brief title)	Ce CRT P-II
Region	Japan

Condition
Condition	cervical esophageal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to investigate the efficacy and tolerability of chemoradiotherapy for squamous cell carcinoma of cervical esophagus
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Treatment compliance CR rate Progression free survival 3-year larynx preservation survival toxicity

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	5-FU(700mg/m2 d1-4)+ CDDP(70mg/m2 d1) q4w+RT(60Gy) 5-FU(800mg/m2 d1-5)+ CDDP(80mg/m2 d1) q4w
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1.squamous cell carcinoma of cervical esophagus 2.performance status:0-1 3.have good organ functions 4.out of adaption of endoscopic resection 5.no prior treatment 6.written informed consent to treatment was obtain
Key exclusion criteria	1.have lymph node metastases at neck level II area 2.have active concomitant malignancy 3.A Hbs antigen is positive 4.pregnant or may be pregnant
Target sample size	32

Research contact person
Name of lead principal investigator	Masato Fujii
Organization	National Tokyo Medical Center
Division name	Dept. of Otolaryngology,
Address	2-5-1Higashigaoka Meguro Tokyo 152-8902, Japan
TEL	04-7133-1111
Email	szenda@east.ncc.go.jp

Public contact
Name of contact person	Sadamoto Zenda
Organization	National Cancer Center Hospital East
Division name	Radiation Oncology Division
Address	6-5-1Kashiwanoha kashiwa chiba
TEL	03-3411-1111
Homepage URL
Email	szenda@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare A grant-in-aid for cancer research plan study
Organization
Division
Category of Funding Organization
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 01 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 10 Month 17 Day
Anticipated trial start date	2008 Year 11 Month 01 Day
Last follow-up date	2013 Year 11 Month 01 Day
Date of closure to data entry	2016 Year 01 Month 10 Day
Date trial data considered complete	2016 Year 01 Month 27 Day
Date analysis concluded	2016 Year 06 Month 01 Day

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

Management information
Registered date	2008 Year 10 Month 19 Day
Last modified on	2016 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001747