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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001439
Receipt No. R000001747
Scientific Title A phase II trial of concurrent chemoradiotherapy with 5-FU plus cisplatin for resectable squamous cell carcinoma of cervical esophagus
Date of disclosure of the study information 2009/01/05
Last modified on 2016/10/26

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Basic information
Public title A phase II trial of concurrent chemoradiotherapy with 5-FU plus cisplatin for resectable squamous cell carcinoma of cervical esophagus
Acronym Ce CRT P-II
Scientific Title A phase II trial of concurrent chemoradiotherapy with 5-FU plus cisplatin for resectable squamous cell carcinoma of cervical esophagus
Scientific Title:Acronym 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
1st name
Middle name
Last name Masato Fujii
Organization National Tokyo Medical Center
Division name Dept. of Otolaryngology,
Zip code
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
1st name
Middle name
Last name Sadamoto Zenda
Organization National Cancer Center Hospital East
Division name Radiation Oncology Division
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2009 Year 01 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2008 Year 10 Month 17 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000001747

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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