UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001439 |
|---|---|
| Receipt number | 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 10:18:11 |
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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
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
szenda@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001747
