UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007379 |
|---|---|
| Receipt number | R000008689 |
| Scientific Title | Developement of minimaly invasive chemoradiotherapy with a method of sentinel lymph node for head and neck cancer |
| Date of disclosure of the study information | 2012/02/25 |
| Last modified on | 2012/02/25 16:27:09 |
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Basic information
Public title
Developement of minimaly invasive chemoradiotherapy with a method of sentinel lymph node for head and neck cancer
Acronym
Minimaly invasive chemoradiotherapy with sentinel lymph node for head and neck cancer
Scientific Title
Developement of minimaly invasive chemoradiotherapy with a method of sentinel lymph node for head and neck cancer
Scientific Title:Acronym
Minimaly invasive chemoradiotherapy with sentinel lymph node for head and neck cancer
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Decision of radiation field by detected of lymphoduct and SLN with 3DCT-LG for head and neck cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
radiation control rate in nomal side LN and completion rate of radiotherapy
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Detect of SLN by 3DCT-LG
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
Patients had untreatement head and neck squamous cell carcinoma ( oral, pharynx, larynx, maxillary sinus) and had over T2 disease with deseased side LN metastases for example N1 or N2b.
1,patient age 20years and above
2,histologically daiagnosed SCC
3,adaptation of radical radiation therapy in primary and neck lesion
4,untreatemented case
5,written informed consent
Key exclusion criteria
1,distant metastasis
2,previously treated patients
3,A history of radiation therapy for the neck
4,pregnancy or lactating women or women with suspected pregnancy
5,Patients judged by the investigator to be unfit to be enrolled into the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jyunkichi Yokoyama |
Organization
Juntendo University school of medicine
Division name
Department of Otolaryngology, head and neck surgery
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University school of medicine
Division name
Department of Otolaryngology, head and neck surgery
Zip code
Address
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Juntendo University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Health and Labor Science Reserch Grant for Clinical Cancer Research
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
| 2012 | Year | 02 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | 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
| 2012 | Year | 02 | Month | 25 | Day |
Last modified on
| 2012 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008689
